![]() |
June 2001
Next Meeting July 18, 2001 New in the Bay Area. . .
Next Meeting The next Community Consortium meeting will be a post-conference update dinner that will be held on Wednesday, July 18th at the Ritz-Carlton. The program will feature a panel providing a "Report Back from Buenos Aires". This is the first year for this International AIDS Society (IAS) meeting that is planned to occur in the odd years where an International AIDS Conference is not being held. The meeting will feature basic and clinical science. The Consortium hopes to offer dinner meeting updates from the three major AIDS conferences held each year -- the Conference on Retroviruses and Opportunistic Infections (February), the International AIDS Conference or the IAS meeting (June or July) and ICAAC (September or October). We are grateful for the support of this endeavor from a number of our local pharmaceutical representatives. The session in July will feature a panel comprised of Consortium physicians who attended the meeting in Argentina. Confirmed speakers include John Stansell, MD, Interim Chief, Positive Health Program at San Francisco General Hospital and Claire Borkert, MD, East Bay AIDS Center. Donald Abrams, MD, will moderate the discussion. Further information will be mailed to you in the near future. In the meantime, make sure you save the date! Please note that this event is open to active consortium members only. This program is sponsored by the University of California School of Medicine at San Francisco (UCSF). UCSF is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to sponsor continuing medical education for physicians. The office of CME designates this continuing medical education activity on an hour-for-hour basis in Category I of the Physicians Recognition Award of the American Medical Association and the Certificate Program of the California Medical Association. In addition, nurses may obtain CEU credits but must keep a record of their own attendance. One hour of credit is available for this meeting.
In addition, we have always claimed that our strength is in our numbers. When the Consortium takes a stance on an issue and, for example, writes a letter to an elected official, it behooves us to say that we are an organization of XXX HIV care providers in the San Francisco Bay Area. Obviously, the larger the number that fills in the blank, the more clout we have. The Community Consortium has much to be proud of. We have been a model for community based clinical trials and provider education in the country for over 15 years. We intend to continue our efforts for as long as they are necessary. We do need and appreciate your support! Please take a moment now to fill out and send back the enclosed 2001 / 2002 membership application. Thanks again for your continued support! AIDS Clinical Grand Rounds on May 23, 2001 featured an outstanding panel presentation on "Continuity of Care for HIV-Positive Inmates". With the HIV population shifts that have been experienced over the past decade, more providers are now caring for individuals making the transition from incarceration to freedom, and vice versa. Our expert panel addressed issues unique to the prisoner with HIV and highlighted some of the local programs available for their assistance. The panelists included Milton Estes, M.D., Medical Director, Forensic AIDS Project, City and County of San Francisco and Consortium Executive Advisory Board Member; Guy Vandenberg, MSW, RN, Director of Forensic Services, Continuum; and Jacqueline Tulsky, M.D., Assistant Clinical Professor, UCSF who has been involved in investigating the outcomes in individuals who commence their use of antiretroviral therapies while in jail. Dr. Estes began the evening by reading quotes from a New York Times editorial from two days earlier on AIDS in Prisons, again showing that Consortium educational programs are right at the cutting edge. The editorial commented that prisons are one of the most dangerous incubators in the epidemic. Healthy inmates run the risk of getting infected with HIV by either sharing needles or sexual contact. All of this occurs in the absence of bleach, condoms and medical care. Data on the frequency of such behavior is unavailable, as one cannot study illegal behaviors occurring in a prison. It has been estimated that 28% of inmates in Tennessee use intravenous drugs. From 9-20% of inmates report having been raped while in prison. Only Vermont and Mississippi have state mandates to offer condoms to prisoners. Others fear that they will be used for drug smuggling purposes if distributed. Offering condoms and/or bleach is largely viewed as sanctioning illegal behavior. It is estimated that there are up to 9000 HIV infected inmates in the state of New York. The editorial suggested that prisons may, in fact, be a good place to educate as well as to offer appropriate health care. Milton stressed the significance of the problem of HIV in incarcerated populations. The incidence is estimated to be 5 to 10 times greater than in the general population. There is significant discontinuity of care as patients come and go in and out of the system. There is a high rate of transmission while incarcerated. These patients are most frequently untreated and poorly educated about the basics of HIV as they receive only episodic medical care. Dr. Estes queried the audience. "How many of you think that you have not taken care of someone who has been incarcerated?" No one in the audience raised their hand! He pointed out that the two million individuals currently incarcerated in the United States represents 25% of all the people incarcerated in the entire world. Where the AIDS rate in the U.S. population is 31.4/100,000, it is 198.5/100,000 in correctional facilities. HIV reporting and data collection is not done, so these are the AIDS rates, not infection rates. The California Department of Corrections estimates that 43-47% of all California inmates are infected with hepatitis C virus- another enormous problem. Eighty percent of California inmates have current or a history of drug use. Twenty-five percent of those currently incarcerated are sentenced because of drug use. Incarcerated women are a lot more likely than women in the general population to have AIDS - again, no information is available on actual rates of HIV infection. Some definitions were provided for those who are not hip to forensic terminology from watching television. Jail is under county control, operated by the Sheriff's Department. Individuals are jailed prior to formal sentencing. The time of incarceration in jail is less than one year. Jail is where misdemeanor offenders are housed. In contrast, prisons are under control of the state or federal government. Individuals are post-sentencing and terms generally exceed one year. A prison houses felons only. Probation is when one receives a conditional release instead of incarceration. Parole is a conditional release given after completing at least part of a term. Community service is mandatory work that is sentenced instead of incarceration. "Serving time" refers strictly to being in prison. There are 33 prisons in California alone. Guy Vandenberg, R.N., M.S.W. reviewed some of the risk behaviors among inmates that promote the spread of both HIV and HCV. Tattooing with reused equipment is a common phenomenon. Body piercing is also performed with shared instruments and is becoming increasingly more common among heterosexual males. Needle-sharing and unprotected sexual intercourse of course are problematic. Inmates often are involved in fights or bonding rituals which involve sharing of bodily fluids. "Keistering" is the transporting of contraband in body cavities which also presents a risk. In one study, 22% of the men and 7.7% of the women reported having had non-consensual sexual intercourse while incarcerated. There are a number of dis-incentives for inmates to access primary care while in prison. Whether or not to disclose pre-existing health status is an issue for most inmates. They fear stigma and segregation as well as loss of privileges. On the other hand, for many prisoners incarceration provides them with their first entry to the health care system. A number of prisons have medical facilities. Health care professionals are often part of the correctional staff and not an independent medical staff. Where medical services are available, there are increased opportunities for prisoners to obtain prevention education, general health education as well as access to health care. Prison offers the opportunity to commence antiretroviral therapy in a very closely monitored setting. However, for the prisoner who chooses to access a primary provider, visits to the clinic take away from work time. In many prisons, the inmates make money and credit time against their sentences by working and work time is sacrificed if they are seeking medical care. Guy went on to describe the situation in some of the California prisons. The California Medical Facility (CMF) at Vacaville houses the largest population of men with HIV and HCV. Segregated housing units as well as hospice care are available at both the CMF as well as the Central California Women's Facility (CCWF) in Chowchilla. A question that he has been interested in is why prisoners with HIV do not continue to seek health care upon release. He described the concept of re-entry programs that have been designed to provide inmates with some structured options for transition back into the community. However, he remarked that many prefer no structure upon release. In San Francisco, most released inmates wind up in the Tenderloin. People get kicked out of Tenderloin hotels after 28 days -- otherwise they would become legal residents- so homelessness is fostered. People used to get re-arrested just for "being" in the Tenderloin, charged by the police with associating with felons because that's where all the felons hang out. The Springboard Program has been effective in getting released prisoners into primary care programs, obtaining ADAP services, etc. post release. Mr. Vandenberg described the results of analysis of outcomes in 71 HIV+ Springboard clients. The goal of the program is to provide transitional case management for people of color with HIV/AIDS released from the CMF, the CCWF and San Quentin. Services are extended to parolees who have been paroled to San Francisco, San Mateo and Marin County and are offered for 6 months pre-release to 2 months post-release. (Contact Helen Lin, 415-437-2900, Helen@continuumhiv.org) Of the 71 HIV+ clients, 31 are alive and out of custody, 21 have been re-arrested, and 15 are awaiting release. Two have died and two are lost to follow-up. All clients were housed immediately upon release. All living, non-fugitive, non-reincarcerated clients attended at least one primary care visit within the first month of release. All clients were enrolled in the AIDS Drug Assistance Program within two weeks of release. All clients were connected to pharmacy services and received medication refills within two weeks of release. All clients receiving HAART while incarcerated continued treatment upon release. Two more began therapy after connecting with their primary care provider through the Springboard program. Dr. Estes next gave a brief history of the Forensic AIDS Project of the San Francisco Department of Public Health Jail Medical Services, outlining particularly the changes that have occurred in administration of antiviral therapies. He has now been affiliated with the program for the past six years, commencing just prior to the availability of protease-inhibitor containing regimens. At that time, there was little initiation of therapy in patients in the jails. They continued, for the most part, whatever regimen they had been on in the outside. With the onset of the HAART era, the Forensic AIDS Project became more proactive about discussing HIV infection with the clients, educating them about the virus and its treatment and beginning antiretroviral therapy. Initially very involved with the question of treatment for tuberculosis and adherence issues, Dr. Tulsky has become quite interested in the question of what happens to those individuals who have begun HAART while in jail once they are released. She opened her comments with praise of Sherriff Hennesey for his openness and concern around these issues. She reviewed some data from the National Clinician's Consultation AIDS "warm line" phone calls. Looking at 1205 phone calls from incarceration sites received from 1991-1999, 66% of all calls came from just 5 states. Thirty-seven percent of the calls came from rural areas. Of the providers calling for information, 28% cared for less than 10 patients with HIV. The mean age of the patients being called about was 37 years. Two-thirds were people of color and a similar percentage had bona fide AIDS diagnoses. CD4+ cell counts were <200/mm3 in 52% and < 100/mm3 in 36%. Dr. Tulsky then reviewed information from 77 inmates released after being cared for by the Forensic AIDS Project since 1997 to assess the level of care provided to patients in the jails. The clients were predominantly African American (52%) men (91%) with a mean age of 38 years who had spent an average of 3 months in jail. Seventy-eight percent had had a CD4+ or HIV RNA level drawn. The mean CD4+ cell count was 335/mm3, with 22% under 200 cells/mm3. The mean HIV RNA level was 20,000 copies/mL with a median of 3200 copies. One-quarter had undetectable HIV RNA. All patients with CD4+ cell counts < 200/mm3 were receiving prophylaxis for Pneumocystis carinii pneumonia. She concluded that the patients care in the San Francisco jail was "right up to par with high-end private practice care ... Inmates may be the only group in the county where health care is a right!" In this cohort, using the 1996 treatment guidelines, all patients eligible for antiretroviral therapy had been offered treatment. Of these, 72% accepted treatment. Seventy-one percent picked up their prescriptions upon release. Of the 15 eligible patients not on therapy, 8 refused treatment, 3 were released prior to picking up their medications and the issue in the remaining 4 was unclear. Now Dr. Tulsky is involved in a project to describe a cohort of patients in real time. Her goals are to assess indicators of disease state and examine the prevalence of genotypic resistance mutations working in collaboration with Robert Grant, M.D., Ph.D., of the Gladstone Institute of Virology and Immunology. All eligible inmates seen by Forensic AIDS Project physicians are eligible for enrollment. Subjects are receiving financial reimbursement for their participation, just as they would if they were "on the outside" and taking part in a trial. She presented information on 53 participants evaluated to date. In the cohort, the mean age is again 38 years with a predominance of African American (55%) males (85%). Forty percent are on SSI/SSD or VA benefits. The majority (83%) have been homeless at some time and 77% have a history of injection drug use while 41% report problem drinking in the past. The mean duration of HIV infection is 7 years. CD4+ count averages 315/mm³ with 28% less than 200/mm3. HIV RNA is undetectable in 36% of the cohort and < 1000 copies/mL (the lower limit of detection for a genotypic resistance assay) in 66%. Only one of the 16 specimens tested demonstrated evidence of resistance mutations. After 6 months of follow-up, over 80% have been located for repeat testing. Fifty percent are still in jail, 17% are back in jail and 7% are in prison. She concludes that it is possible to identify and follow a cohort of HIV-infected people in county jail. In addition, it is possible to achieve successful suppression of HIV while being treated in the jail setting. Dr. Tulsky believes this is all the more remarkable when one considers that the correctional facilities have become the de facto mental health facilities in this country. The issue of the care of the incarcerated patient with HIV will only become larger with time. The panelists were thanked not only for their outstanding informative presentation but also for the work that they are doing in serving this unique patient population.
Committee Reports
The Community Consortium Executive Advisory Board will meet on Wednesday, July 25, 2001 at 7:30 a.m. in the Community Consortium conference room. The EAB met on June 6, just after the CPCRA group meeting held in Washington, D.C. earlier that week. Spirits were high at the group meeting as the CPCRA's proposed Strategic Management of Antiretroviral Therapy (SMART) protocol has been favorably reviewed by the Division of AIDS. Funding for the CPCRA is now assured for the upcoming years. The SMART trial hopes to enroll 6000 participants and follow them over 6 to 8 years to assess two different treatment strategies in HIV infection -- a Drug Conservation (DC) strategy and a Viral Suppression (VS) strategy. The study will be open to any individual with CD4+ count > 350/mm3, regardless of their antiretroviral therapy status. Subjects randomized to the DC strategy will be asked to discontinue their antiretroviral regimen until such time that their CD4+ count falls to < 250 cells/mm3. Those naïve to treatment will be asked to remain so until reaching that CD4+ threshold. Individuals randomized to the VS will continue on or begin antiretroviral therapy with a goal of maintaining viral suppression as low as possible for as long as possible. It is likely that the SMART study will be piloted by the current CPCRA to assess the feasibility of the study and then expand to include additional participating sites The goal is to launch the trial in October 2001. More information on SMART will be forthcoming in the coming months. A dinner for interested investigators will be planned. October 24, 2001 is a possible date. Please pencil it in! The Community Consortium will become a National Trial Coordinating Center (NTCC) of the ESPRIT trial. The Evaluation of Subcutaneous Proleukin in a Randomized International Trial is very similar to CPCRA 059, the evaluation of two different dosages of interleukin-2. However, in ESPRIT, participants will only be randomized to receive either interleukin-2 7.5 MIU subcutaneously twice a day for 5 days every 8 weeks or no treatment. As well, instead of monthly visits as in the CPCRA study, ESPRIT data collection only occurs every 4 months. We hope that this study will be open for enrollment for interested patients sometime in the very near future. The study is designed to assess clinical benefit of IL-2 and hence will enroll 4000 patients worldwide and follow them for disease progression events for a minimum of five years. Participants randomized to the IL-2 arm will repeat cycles of therapy to maintain their CD4+ T cell counts at twice baseline or above 1000 cells/mm3. If you have patients who may be interested in ESPRIT, stay tuned for further information concerning the launch of the study. The University of California Center for Medicinal Cannabis Research (CMCR) has approved its second set of proposals for the study of cannabis as treatment for specific medical conditions. Eight additional studies from various California research institutions were recommended for funding by the CMCR's independent Scientific Review Board following rigorous scientific review. A study submitted by Donald Abrams and collaborators at the UCSF Pain Clinical Research Center to evaluate the effect of marijuana on pain from bone metastases in patients with breast and prostate cancer is undergoing application to the numerous regulatory bodies at this time. The study will be similar to the HIV peripheral neuropathy study that we hope to begin this summer. Both pilot trials will be a short General Clinical Research Center inpatient studies. Additional information will be available as the study gets closer to being launch. The EAB also noted the construction going on at the Consortium offices at 18th and Folsom. Pioneers in our building, the Consortium is being joined by the remainder of the Positive Health Program clinical research programs at our site. The Adult AIDS Clinical Trials Group (AACTG) moved to the facility over a year ago. Now the remaining clinical research investigation staffs are joining us, moving from cramped quarters in various locations on the San Francisco General Hospital campus to consolidate our resources and efforts at what is being affectionately called "PHP West". This is a time of some change for the Consortium staff as well as our physical plant. Bear with us if you are trying to call or visit during this transition.
Consortium Clinical Trials The Consortium wishes Jane Pannell, R.N. the best in her new position as an Alzheimer's research nurse at the University of California San Francisco. Jane has been a valued member of our clinical research nurse staff for the past eight years. She will be missed by all who had the opportunity to work with her. We welcome David MacLeod, R.N., previously of the GI Clinics at UCSF who is joining our research nursing staff. David will be staffing Consortium trials at the SFGH Positive Health Program and UCSF AIDS Clinic. Please welcome David to the Consortium. The first 60 of the target 150 participants have now been enrolled in this clinical trial being conducted in collaboration with Elisabeth Targ, MD, principal investigator of this NIH-funded study to investigate distant healing by nurses and healers as an adjunctive intervention in AIDS. On the basis of provocative preliminary data, this larger study is being conducted to further evaluate the impact of these interventions. The study will be completed in 10 cohorts of 15 patients. In each cohort, five patients will be randomized to receive DH attempts by professional "healers", five patients will receive DH attempts by nurses, and five patients will receive no special intervention beyond usual medical treatments. The study will be double-blinded so that neither patients nor their doctors nor the researchers will know who is receiving the healing treatments. Outcome measures include the clinical course, psychological course, utilization of medications as well as HIV RNA, CD4/CD8, NK cell function, and metabolic measures and antiretroviral therapy toxicity. Inclusion criteria are HIV sero-positive between the ages of 18 and 65 with a history of having had a CD4+ cell count < 200/mm3. Patients who are not English-speaking, unable or unwilling to fill out questionnaires or who have a history of non-HIV related life-threatening disease are excluded. Study procedures will be conducted at the California Pacific Medical Center site. Participants will be required to return after their baseline evaluation to this study site at six months and one year for follow-up questionnaires and blood work. The remainder of the data will be extracted from clinic charts by the research assistant. If you are interested in enrolling eligible patients for the distant healing study, please contact Paul Couey at (415) 502-5705. We have now enrolled 7of the target 40 patients onto the study of dehydroepiandosterone (DHEA) to investigate how it impacts on latent HIV replication and host immunity. DHEA has been touted to have a number of beneficial effects in patients with HIV from antiviral to immunomodulatory as well as being an agent to increase lean body mass and improve quality of life. There is some evidence to suggest that DHEA may have potential benefit in purging the latent pool of HIV in resting cells. To this end, this randomized placebo-controlled trial will be open to patients fully suppressed on an antiretroviral regimen. Eligibility criteria include patients with HIV-1 infection who are 18 years or older on stable antiretroviral regimens for at least eight weeks, with HIV RNA < 50 copies/ml. Women must have a normal PAP smear and mammogram within the past year and men are required to have a normal prostate specific antigen level within the past year. Participants will be randomized in a 1:1 ratio to receive either DHEA (100 mg po twice daily for males, 50 mg po twice daily for females) or placebo for 12 weeks. All study participants will then receive DHEA for an additional 12 weeks, for a total study duration of 24 weeks. Study participants will be seen as outpatients at the General Clinical Research Center. They will have one screening and one baseline visit prior to starting study drugs. At the baseline visit, they will have blood drawn for measurement of HIV RNA, viral DNA, hormone levels, lipid levels, PSA, serum chemistries, and lymphocyte subset analyses for activation antigens and naive and memory T-cell subpopulations. Body weight, height, anthropometric measures as well as body composition measurements by DEXA will be obtained. Quality of life assessments will be completed. Participants will then be randomized to either DHEA or placebo for 12 weeks. Follow-up study visits will occur at weeks 2, 4, 6, and 12. Visits during the ensuing 12-week open label DHEA treatment will occur at weeks 18 and 24. If you have patients who may be interested in participating in this study, please contact Paul Couey at (415) 502-5705. Although we remain the national leader in enrollments to the CPCRA MDR protocol largely due to the efforts Michael Jones, RN, Community Consortium research nurse and the providers at Castro-Mission Health Center, accrual has slowed considerably over the past few months. We have enrolled 19 patients of the 140 accrued throughout the CPCRA. The study is being modified in hopes of liberalizing enrollment criteria and Version 2.0 is being submitted to local IRB?s in the next few weeks. Although many are now less eager to enroll advanced patients on a structured treatment interruption (STI), the study was reviewed by the Data Safety Monitoring Board of the NIAID in February and was given the green light to proceed. The protocol team suggested another DSMB review in June to assure safety, but the DSMB felt that the scheduled review in October was adequate. This is now the largest randomized STI trial accrued to date. This study of a STI in patients with multi-drug resistant (MDR) HIV is a randomized clinical endpoint study to determine whether a prescribed four-month STI will delay clinical disease progression and death compared with a strategy of immediately initiating a new antiretroviral regimen in patients with MDR virus. Subjects will initiate the salvage regimen based on information generated from both genotypic and phenotypic resistance testing that is provided as part of the protocol. As there is little existing information on the optimal amount of time to wait before resuming therapy following an STI, the first 150 participants in the CPCRA trial will have point mutation assays performed. These are more sensitive than routine resistance assays. These initial patients will also undergo more frequent HIV RNA testing, which should enable the investigators to know early in the course of the trial whether four months is too long or too short of an STI. Four-hundred-eighty subjects will be randomized in the trial over a 12-month accrual period. This will make this, by far, the largest STI trial conducted to date. Participants will be followed monthly for the first 8 months, and then every 4 months. Should CD4 cell counts drop below threshold levels, prophylaxis for opportunistic infections will be resumed. This study will provide much information on the kinetics or the return of CD4 cells following the reinstatement of an antiviral regimen, as well as much clinical information over its planned two years of follow-up. Entry criteria includes age > 13 years with HIV RNA >10,000 copies/ml. This will be changed to > 5000 copies in the upcoming version. The potential subject must have demonstrated a multi-drug-resistant HIV strain on genotypic antiviral resistance testing (GART), with evidence of broad PI resistance combined with broad NNRTI and/or broad NRTI resistance. The patient and provider must have the intention of initiating a new regimen and should be able to accept the potential timing of this change as specified in the protocol. Individuals should be on a stable antiretroviral regimen for at least 14 days prior to the qualifying GART test and randomization. Broad PI resistance is defined as having at least two major resistance mutations against PIs. Broad NNRTI resistance would include the 103M mutation or a combination of two other NNRTI mutations. Broad resistance to nucleosides is defined as the presence of 151M/69S mutation or a combination of mutations including the 215Y/S mutation. Any patient previously exposed to three nucleosides, one NNRTI and two PIs, is also eligible for screening and will have GART performed if they meet the remaining entry criteria. These criteria are also under revision in Version 2.0 to increase potential eligibility. If you have any individuals who may be interested in participating in the CPCRA MDR trial, please let your Community Consortium clinical research nurse know! The CPCRA's Flexible Initial Retroviral Suppressive Therapies (FIRST) trial is the entry point into the CPCRA's menu of strategic antiretroviral studies. FIRST is open to patients who are antiretroviral naive. The CPCRA now has 1,138 current enrollments. The Consortium has contributed 44 patients to the study. The question being asked is "What constitutes the best initial regimen for patients beginning antiretroviral therapies?" Patients are randomized to one of three arms. One arm includes two nucleoside analogs and a protease inhibitor, a second arm includes two nucleoside analogs and a non-nucleoside reverse transcriptase inhibitor (NNRTI), and a third arm includes at least one nucleoside analog plus an NNRTI and a protease inhibitor. Clinicians who so desire have free reign to choose all of the drugs that the patient begins within the classes to which patients have been randomized. If providers have equipoise among the various protease inhibitors and NNRTIs, patients may undergo a second randomization to specific drugs within the class. With the increasing untoward consequences that are being seen from highly active antiretroviral therapies and the increasing number of agents available in our antiretroviral armamentarium, the FIRST study is poised to answer a very timely and pertinent question. Patients are eligible regardless of their CD4+ cell counts or their HIV RNA levels. In this strategic trial, no drugs are provided; drugs are all currently available by prescription. When a patient is randomized, the provider will write a prescription for the appropriate regimen. The endpoint in the study will be the time to second virologic failure. This endpoint takes into account the fact that it is likely that all of the regimens may be nearly equivalent in their initial ability to suppress HIV RNA. The real differences may appear when switching patients to a second regimen once patients have progressed. Thus, the FIRST trial has a rather unique clinical endpoint. It is hoped that all patients enrolled will also be co-enrolled in the CPCRA long-term monitoring protocol, to allow us to collect further information on clinical status of the patients. A perplexing question that still baffles HIV care providers is the etiology of the body habitus alterations and metabolic consequences of highly active antiretroviral therapies. Are these changes related to protease inhibitors alone? Are the same consequences seen in patients who being therapy with an NNRTI-containing HAART regimen? To answer this study, the CPCRA designed the Metabolic Trial as a substudy of FIRST. The trial will capture information from patients as they enroll onto the FIRST trial. Patients will undergo serial metabolic evaluations, including laboratory testing and anthropomorphic measurements. By co-enrolling patients from the FIRST trial, we hope to be able to get answers to the question as to whether changes in body habitus alterations and metabolic abnormalities being seen in patients on HAART are related to protease inhibitor therapy or are seen with equal frequency in patients commencing an NNRTI-containing regimen. Patients enrolled in the metabolic study will undergo measurements of glucose, insulin, cholesterol and triglyceride levels. In addition, body composition measurements (e.g., BIA, skinfold measurements and body circumference measurements) will also be obtained. This trial promises to contribute much valuable information on risks and rates for developing metabolic and body habitus alterations after initiating HAART. The CPCRA has over-enrolled the metabolic study, with 397 patients currently being evaluated at this time. How to ensure that our patients can best adhere to the complicated HAART regimens that we prescribe is a most important question. Unlike most CPCRA studies where the individual patient is randomized to one intervention or another, the adherence study has randomized the entire Community Consortium to an adherence intervention that utilizes the services of "medication managers." Patients co-enrolled onto a CPCRA strategic antiretroviral trial who choose to participant in the adherence substudy will have interactions with our trained medication managers. These Consortium clinical research nurses will do everything per protocol to ensure that patients are reminded to adhere to their prescribed regimens. Two different interventions are being evaluated in a two-by-two factorial design involving CPCRA units randomized to different arms across the national network. The ultimate goal will be to evaluate which intervention produces the best HIV RNA results as well as self-reported adherence. The CPCRA has over-enrolled the adherence study, with 744 patients being followed at this time.
The CPCRA is committed to long-term evaluation of patients enrolled on randomized clinical trials. Where a number of our studies have intermediate surrogate marker endpoints, co-enrolling patients onto the long-term monitoring (LTM) protocol will ensure that we are able to capture long-term disease progression and survival information on patients who may not have already reached a clinical endpoint. Currently, we are working to enroll all patients from CPCRA randomized interventional trials onto LTM. The Consortium has a goal of 100% co-enrollment onto the LTM protocol for eligible patients. To date, 2,537 patients are being followed on the LTM nationwide, including 100 from our site. New in the Bay Area . . .
Post Exposure Prevention (PEP-2) Study is currently enrolling participants. This study which is being conducted by UCSF Positive Health Program and the San Francisco Department of Health, is a randomized trial to compare the effect of standard counseling (2 sessions) versus enhanced risk reduction counseling (5 sessions) on risk behavior in individuals receiving PEP. If you would like to refer a patient or receive more information regarding this study, please call 415-514-4737. The Bay Area Research Consortium on Women and AIDS is still actively recruiting HIV + women to participate in a study entitled ?Effect of the ovulatory cycle on HIV 1 dynamics?, also know as the Dynamic Study. This study is investigating the effects of the ovulatory cycle and thus sex hormones on HIV-1 dynamics after starting highly active antiretroviral therapy (HAART). If you have patients who may be interested in participating in this study, please contact the project staff at 415-502-5355 or via pager at 415-719-0629. John Tambis, Disease Intervention Specialist, Sexually Transmitted Disease Program of the San Francisco Department of Public Health, attended the May meeting and presented some alarming statistics regarding the rate of syphilis among men having sex with men in San Francisco. Whereas there were only 5 cases reported in 1999, the number tripled to 15 in 2000 and, to date, there have been 29 new cases in 2001. Most of the recently diagnosed cases have been infectious cases (primary, secondary or early latent) indicating recent acquisition. Half of the new syphilis cases have been diagnosed in HIV positive men. This has led the DPH to recommend that RPR's be drawn at least twice a year in sexually active individuals, if not each time an HIV RNA is drawn in following HIV positive patients. While questions followed regarding the cost-effectiveness of such a recommendation, the cost of testing is low [$13.20 for provider and $34.00 for client at Unilab]. Copies of the new "Guidelines for STD Clinical Preventive Services for Persons Infected with HIV" were distributed. |
About | Education & Information | Research | Membership | Contact | Search | Home UCSF | Positive Health Program 3180 18th Street Suite 201 | San Francisco, CA 94110 Copyright 1999-2000 University of California Regents. All Rights Reserved |