february 2000
Next Meeting: February 16, 2000
Report from the January
AIDS Clinical Grand Rounds
The Yin and Yang of STDs and HIV
Committee Reports
Executive Advisory Board
Scientific Advisory Committee
Community Advisory Board
Consortium Clinical Trials Open for Enrollment
FIRST
Metabolic Study
Adherence Study
Protease Inhibitor Progression (PIP)
Long-Term Monitoring (LTM)
THC
HIV Negative Subjects Sought
Treatment Interruption
T-20
Pegylated Interferon
Thought You'd Like to Know . . .
California Academy of HIV Medicine Launched
Donald I. Abrams, MD, Editor
The next meeting of the Community Consortium will be held on Wednesday, February 16, 2000 at 6:00 p.m. at the Davies Campus of the California Pacific Medical Center in the auditorium on B Level at Castro and Duboce Streets in San Francisco. Refreshments will be served and free parking is available in the lot
Following brief announcements, AIDS Clinical Grand Rounds will feature an update from the 7th Conference on Retroviruses and Opportunistic Infections (CROI). This year's CROI is being held in San Francisco January 30 through February 3. It is likely that many Consortium providers will be able to attend the conference. At the same time, often so much information is presented at these meetings that it is difficult to assimilate everything. So, regardless of whether you were able to attend or not, coming to the February 16 AIDS Clinical Grand Rounds review session will certainly help you to put the major new findings presented into perspective. As has become the Consortium tradition, any provider who attends the conference is invited to bring back what they feel is a valuable clinical pearl to share with colleagues. In addition to comments from the general Consortium membership, a panel including Steven Deeks, MD, Stephen Follansbee, MD and William Owen, MD will join me in providing a general overview of the meeting. As always, these reviews provide a lively and interactive forum for participation. Please make every effort to attend!
This program is sponsored by the University of California at San Francisco (UCSF) School of Medicine. 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.
AIDS Clinical Grand Rounds: The Yin and Yang of STDs and HIV
The January 2000 AIDS Clinical Grand Rounds featured a presentation by Jeffrey Klausner, MD, MPH, Director of the San Francisco Department of Public Health STD Prevention and Control. Dr. Klausner's presentation, entitled "The Yin and Yang of STDs and HIV," provided a most informative and comprehensive discussion of the interaction of HIV infection with more treatable sexually transmitted diseases. Dr. Klausner began his presentation by discussing the significance of his title. Yin aspects of his discussion focused on the more negative or dark interactions between STDs and HIV whereas Yang discussion points highlighted more bright positive features. As an example, a Yin talking point demonstrated how STDs affect HIV. Urethral gonococcal infection increases seminal HIV levels. Genital herpes increases HIV shedding. Cervicitis and vaginitis also lead to increased HIV in general tract secretions. Dr. Klausner cited a Lancet article that demonstrated that control patients had an HIV titer of 4.5 log in their semen. Any sexually transmitted disease tended to increase the mean titer to 5.0 log. With treatment, values dropped to baseline. GC urethritis tended to lead to the greatest increase in viral shedding. Non-gonococcal urethritis led to no increase in seminal fluid HIV and subsequently no change following therapy. There has been clearly documented evidence that a number of sexually transmitted diseases contribute to increased HIV transmission. Among them are genital ulcer disease, urethritis, cervicitis/vaginitis and proctitis. Dr. Klausner pointed to data from a 1996 HIVNet cohort of 3,257 men who have sex with men (MSM) enrolled in 1996 in six cities, to demonstrate the relationship between sexually transmitted diseases and HIV transmission. Follow-up information after 18 months is provided. The HIV seroincidence is 1.5 (1.2-1.9) with 71 MSMs seroconverting during the follow-up period. There was no decline in the rate of seroincidence over time. In looking at independent risk factors for conversion, a history of GC or chlamydia yielded an odds ratio of 3.1. The less than 35 age group had an odds ratio of 1.8 but an attributable fraction (AF) of 34 percent compared to 9 percent for the increased risk of chlamydia or gonorrhea. Dr. Klausner explained the attributable fraction as a useful statistic for the epidemiologists. It describes what percent of cases overall were related to the particular risk factor. For example, despite higher odds ratio for seroconversion, the lesser frequency of GC or chlamydia compared to men aged less than 35 allow the attributable fraction to be only 9 percent in the GC or chlamydia group compared to 34 percent for the younger men. Injection drug use had an odds ratio of 3.0 for seroconversion with an attributable fraction of 4 percent; being uncircumcised OR = 2.1 AF = 10%. Use of nitrate inhalants (poppers) had an odds ratio of 2.0. This finding was corroborated by the CDC Jumpstart Study which looked at acquisition of HIV in three cities. Again, urethritis had an OR of 2.3, AF 9%. In this study, unprotected rectal intercourse had an OR of 2.4 with an AF of 35 percent because it was more commonly reported than the STD. Dr. Klausner reviewed the impact of sexually transmitted diseases on local inflammatory response. STDs cause an increase in HIV target cells, i.e., macrophages and CD4 lymphocytes. STDs also cause increased activation of the target cells as well as increased cytokines, particular TNF-alpha, IL-2, IL-10 and IFN-gamma. These factors again would seem to favor transmission of HIV in patients with STDs. Can reduction in STDs conceivably lead to decreased HIV transmission? This question was investigated in a study in Mwanza, Tanzania where treatment of symptomatic STDs led to reduced HIV transmission. This was the first large study of its kind to demonstrate this benefit. Villages were divided in half. Individuals with symptomatic STDs were treated in half the villages but not in the other half. A 40 percent reduction in transmission of HIV was noted in villages that were treated for STDs. The reductions were consistent in both women and men and across all age groups. The study was instrumental in leading to the establishment of STD programs in developing nations as a means of HIV prevention. Interestingly, Dr. Klausner described a Ugandan study in which mass treatment of asymptomatic STDs failed to show a reduction of transmission. He suggests that perhaps the difference was the reduction in inflammation that accompanied treatment of symptomatic but not asymptomatic STDs. Another Yin interaction between HIV and STDs was the fact that HIV impacts upon viral STDs. Because of the immunosuppression associated with HIV, negative effects are to be anticipated in viral STDs. And, in fact, it has been shown that HIV leads to increased HPV, both in the cervical and anal areas, increased HHV8, and increased herpes recurrences. The impact on hepatitis A, B and C disease related to hep B, is postulated but at this point remains unclear. Whereas the viral infections are controlled by cell-mediated immunity, HIV has little effect on bacterial STDs. For example, gonococcal infections and chlamydia are easily diagnosed and treated in patients with HIV. Both of these diseases are managed by phagocytes and not related to cell-mediated immunity; hence no problems are encountered. There have been reports, however, of increased tubo-ovarian abscesses in women with PID from a study emanating from Kenya. Dr. Klausner reviewed the recently updated CDC 1998 Guidelines for Treatment of Bacterial STDs. For uncomplicated gonorrhea involving the pharynx, rectum, urethra or cervix, cefixime 400 po once is effective therapy. There is no difference in efficacy for HIV+ versus HIV- individuals. For chlamydia infections, doxycycline 100 mg bid for seven days is an option although azithromycin 1 gm po x 1 is better for directly observed therapy. There is a bit more controversy as to whether HIV and syphilis have any significant interactions. Dr. Klausner reported that the nation is currently engaged in a syphilis elimination effort. This is the third time in the history of modern medicine that this kind of a mass effort has been mounted. In reviewing the controversy regarding HIV and syphilis, Dr. Klausner reported that case reports and review articles in the late '80s and early '90s suggested that HIV+ individuals had a more protracted and malignant course of syphilis. In addition, two cases of seronegative (RPR-) biopsy proven secondary syphilis were reported in the literature. This led many to doubt whether standard diagnostic tests or therapeutic interventions were actually efficacious in management of HIV+ patients. Dr. Klausner described the multicenter randomized double-blind controlled trial of enhanced therapy for early syphilis in patients with and without HIV infection (NEJM 1997;337:307-14). 541 patients were included in the study population of which 101 (18.7 percent) were HIV+. Patients were randomized to receive standard therapy for early syphilis, which is 2.4 million units of penicillin G benzathine versus that therapy enhanced with a 10-day course of amoxicillin and probenecid. The study demonstrated that enhanced treatment with amoxycillin and probenecid did not improve the outcomes. There was no difference in the rate of resolution of the chancre or rash. There was no difference in the prevalence/incidence of neurosyphilis. There was only one actual treatment failure in the entire cohort in an HIV+ patient who received penicillin only. Although the clinical cure rate was excellent, there was a similar 14 percent serologic failure rate at 12 months in both the HIV+ and HIV- individuals. Hence, no enhanced therapy is required for individuals with HIV and syphilis. The CDC now recommends routine STD screening of HIV+ individuals because (1) STDs promote increased shedding of HIV, (2) HIV+ patients are generally under medical care and (3) there are fewer HIV+ patients than HIV- individuals. In the spirit of these recommendations, the San Francisco Department of Public Health ran a pilot study at the Positive Health Program at Ward 86 in September of 1999. A group of 402 HIV+ patients who were asymptomatic with regards to sexually transmitted diseases were screened on their clinic visits that month. Among the 402 patients screened, there were no cases of urethral or cervical GC, and no new cases of syphilis diagnosed. Two cases (0.5 per cent) of urethral or cervical chlamydia were diagnosed. This low yield may, in fact, temper the recommendations on how intensive one need be with STD screening in the population. However, Dr. Klausner warned that these low yield results may be confounded by the widespread use of septra as PCP prophylaxis as well as the impact of antiretroviral therapy, which may have some antibacterial efficacy as well. In any event, the current CDC recommendations suggest that at baseline one should obtain an RPR; cervical/urine chlamydia and GC, pharyngeal GC culture, rectal GC culture, herpes type specific serology, hepatitis A and B serology and a PAP smear. These baseline studies should be repeated every 6 to 12 months. Dr. Klausner was questioned on the wisdom of doing all of these cultures in asymptomatic patients in view of the findings from the SFGH study. He reported that in another recent survey, conducted by the SFDPH, asymptomatic pharyngeal GC infection was diagnosed in 12.5 percent of individuals reporting frequent oral sex contact. Dr. Klausner then turned to standard reporting mechanisms. The laboratories report positive GC cultures, syphilis virology and chlamydia tests to the health department automatically. Cases of syphilis trigger provider contact, treatment verification and partner management. Certain cases of gonococcal and chlamydia disease may also trigger treatment verification and partner therapy. He pointed out that AB-648 is a bill which allows the physician to write a prescription for the partner or give extra medications to the patient he is treating to be used for that individual's sexual partner. One can also request reimbursements for treatment of sexual partners. John Tambis, a Disease Control Officer from the San Francisco Department of Public Health STD Prevention and Control Division, was introduced. Mr. Tambis' job is to report back to physicians when STDs are reported to the DPH. He subsequently reports back to partners when warranted. In the current syphilis elimination program, Mr. Tambis described the contact elicitation system that has been set up to interrupt the cycle of syphilis transmission. He reminded providers that they should look upon this as a service. The goal is getting partners of early syphilis cases evaluated for syphilis. The patient can maintain anonymity throughout. He requires assistance from physicians locally by encouraging their patient to cooperate with the Department of Public Health. Physicians should also let their patients know of the existence of the program. Mr. Tambis reported that he will adapt the needs of the contact elicitation program to get the most information available. His goal is to work to do whatever works best in any given office. He also asks for creative ideas to encourage resistant patients to cooperate. Dr. Klausner and Mr. Tambis were thanked for all of their hard work and for this very valuable update on the interaction between HIV and STDs.
Committee Reports
The next meeting of the Community Consortium Executive Advisory Board will held be on Wednesday, March 29, 2000 at 7:30 a.m. in the Community Consortium conference room. During these times of uncertain funding for the Consortium's Clinical Trials Program, the Executive Advisory Board is discussing diversification of the Consortium's areas of investigation beyond HIV disease.
The January Saturday CME program, "HIV into the New Millennium," took place on Saturday, January 15. The program presented an excellent overview of problems facing us locally and globally as we continue to deal with HIV now into the third decade. Kimberly Page Schaefer, MPH, PhD, presented a sobering picture of "The Global HIV Epidemic." Ronald Stall, PhD, of the Center for AIDS Prevention Studies, discussed "Challenges Facing HIV Prevention Programs." This was a timely presentation for Dr. Stall, who is now moving on to take a position at the Centers for Disease Control as Branch Chief for Behavioral Interventions for Disease Prevention. Susan Buchbinder, MD, Director of the HIV Research Section at the San Francisco Department of Public Health, described "Advances in Vaccine Development."
New diagnostic technologies were discussed by Robert Grant, MD, MPH, of the J. David Gladstone Institute of Virology and Immunology. William Owen, MD, gave an extremely comprehensive overview of "New Developments in Antiretroviral Therapies." The program was supported by generous unrestricted educational grants from Agouron and SmithKline Beecham, to whom we are most grateful. The Executive Advisory Board is currently planning a Spring program on practical clinical aspects of HIV care and management. Stay tuned for further details regarding a date for this Saturday half-day CME program.
Scientific Advisory Committee
Community Advisory Board
Consortium Clinical Trials Open for Enrollment
The CPCRA Flexible Initial Retroviral Suppressive Therapies (FIRST) trial is the entry point into the CPCRA menu of strategic antiretroviral trials. FIRST is open to patients who are antiretroviral naive. The question being asked is "What constitutes the best initial regimen for patients beginning antiviral therapies?" Patients will be randomized to one of three arms. One arm will include two nucleoside analogs and a protease inhibitor, a second arm will include two nucleoside analogs and a non-nucleoside reverse transcriptase inhibitor (NNRTI), and a third arm will include at least one nucleoside analog plus an NNRTI and a protease inhibitor. Clinicians who so desire will 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, which is still in development. This will allow us to collect further information on clinical status of the patients.
A perplexing question that baffles all 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 has launched the Metabolic Trial as a substudy of FIRST. The trial is designed to capture information from patients as they enroll onto the CPCRA 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.
How to ensure that our patients can best adhere to the complicated HAART regimens that we prescribe is a most important question. Among the FIRST family of accompanying clinical trials, the CPCRA Adherence Study is now open for enrollment. 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.
Congratulations to Robert Scott, MD and Paula Pell, Consortium Clinical Research Nurse for enrolling our first adherence patient.
Protease Inhibitor Progression (PIP)
The revised version of the PIP protocol is now open for enrollment. The study is now more clearly presented as four concurrent companion trials under one master protocol. Two strategies are being evaluated. In patients progressing on a FIRST protease inhibitor-containing regimen, who still have adequate nucleoside analog options from which to choose, the strategy question will be one of intervening with immediate versus differed non-nucleoside reverse transcriptase inhibitor (NNRTI) therapy. Patients will be randomized to begin two protease inhibitors or two protease inhibitors and an NNRTI. The specification of the actual drugs to be used, which was found in the initial version of PIP, has now been removed to allow providers to choose among protease inhibitors and NNRTIs. This study is open to patients progressing either on nelfinavir/ amprenavir or indinavir/ritonavir as their initial protease inhibitor treatments. For those patients progressing with limited options of nucleoside reverse transcriptase inhibitors to employ in their next regimen, the strategic question will be whether one or two protease inhibitors in conjunction with an NNRTI is the best salvage regimen. In these studies of PIP, patients progressing on their initial protease inhibitor regimen will be randomized to switch to one or two protease inhibitors and all patients will receive an NNRTI.
Patients must have a viral load >500 copies/ml. All patients will receive baseline genotypic resistance testing and the results will be returned as soon as available to the provider. There is no CD4 cell restriction. The question of how to best manage patients progressing on their first protease inhibitor-containing regimen is still largely unanswered. A survey of the Science Planning Committee of the CPCRA at the recent September meeting revealed that the options available in PIP correlate with the regimens that providers are offering to their patients off protocol. PIP is one of the first randomized trials looking at the question. In this CPCRA strategic trial, no drugs are being offered to the patient. Once the patient is randomized, the drugs will be obtained through provider prescription. We are quite eager to enroll as many of your progressing patients onto this protocol as possible.
The CPCRA is committed to long-term evaluation of patients enrolled on randomized clinical trials. Where a number of our trials have intermediate surrogate marker endpoints, co-enrolling patients onto the 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. Our goal is to enroll all patients on the CPCRA core protocols (FIRST and PIP) onto LTM. In this way, even if and when patients reach the endpoint of a clinical trial, they will continue to be followed for disease progression and survival, adding further information to the large CPCRA database. There are no specific laboratory tests. There are no specific laboratory tests required in the LTM trial. Patients are followed at every four-month intervals and CD4 cell and HIV RNA levels that have been drawn as part of their routine clinical care will be collected and reported. Your Consortium clinical research nurse will be making every effort possible to enroll all of your eligible patients onto long-term monitoring.
In addition to patients participating in CPCRA trials, LTM is also open for two other subsets of patients of interest. If you have an antiretroviral naive patient who is offered enrollment onto the CPCRA FIRST trial but who declines to participate in the randomized trial, we are interested in capturing their outcome information by enrolling them onto LTM. Similarly, antiretroviral naive patients who are choosing to remain antiretroviral naive are also being offered enrollment onto the LTM study. In this way, we will be able to amass a significant amount of standardized information on the cohort of patients who remain antiretroviral naive. Enrollment of these patients onto LTM will also facilitate subsequent enrollment onto other CPCRA intervention clinical trials.
Fifty-four patients have now been enrolled in the Consortium study of the short-term effects of cannabinoids in patients with HIV infection. Only 12 more are needed currently to complete the trial. It is hoped that the study will be ready for analysis by mid-2000. The goal of the study is to determine whether there is any pharmacokinetic interaction between cannabinoids (oral or smoked) and protease inhibitors, specifically indinavir and nelfinavir. We are hoping to enroll 32 patients on each of these protease inhibitors. We are almost at our target for nelfinavir. Additional indinavir patients are needed. In addition, the majority of patients enrolled to date have been men. It is important for us to be able to investigate these potential interactions in women as well. Therefore if you have any patients on indinavir or any women who may interested in participating in the trial, please have them call the number below for more information.
During the 25-day in-patient evaluation at the GCRC, patients will be randomized to smoke THC three times daily or to oral marinol three times daily or to marinol placebo. Immune parameters, HIV RNA levels, testosterone levels, body composition and pharmacokinetic measurements will be obtained. Patients will receive up to $1,000 for completion of the study. They will also be contributing important information that will help to provide some data for the current debate regarding the safety and medical utility of smoked marijuana. Eligibility criteria include prior history of use of marijuana (none in the month prior to randomization), stable viral load and stable antiretroviral regimen (including either indinavir or nelfinavir as the sole PI) for at least eight weeks. Patients who are tobacco smokers, on methadone maintenance, taking anabolic steroids or who are pregnant will be excluded. If you have patients who are interested in participating in the trial and who appear to meet the eligibility criteria, please have them call (415) 502-5705 for further information.
Just Opened in the Bay Area
Mustafa Noor, MD, a post-doctoral fellow working in collaboration with Kathleen Mulligan, PhD, Morris Schambelan, MD, Joan Lo, MD, Carl Grunfeld, MD, PhD, and the metabolic staffs at VA Medical Center and San Francisco General Hospital are seeking HIV-negative healthy volunteers to participant in a clinical research trial. That will look at the effect of protease inhibitors on metabolic parameters in uninfected individuals. The goal is to determine which of the metabolic changes may be related to the drug and what are related to the interactions with HIV. Participants are studied twice for five days in the San Francisco General Hospital General Clinical Research Center at the beginning and at the end of the trial. In the interim, they take indinavir 800 mg 3 times a day for 30 days. Individuals receive $1000 for completion of this study. For more information, contact Dr. Noor at (415) 750-2005.
Treatment Interruption
This study will look to see if it is safe to interrupt HAART and to see if an immune response is enhanced with successive periods of treatment interruption. Patients entering the study will remain off antiretroviral therapy for 60 days, then restart their previous HAART regimens for 14 weeks. Patients who again achieve full viral load suppression (<50 copies/mL) will qualify for additional treatment interruption cycles. In addition to blood tests, patients will receive skin tests and thymus CT scans over the course of the study. The study lasts 15 months. When patients are off treatment, they will have study visits once a week. While on treatment, study visits are at Weeks 1, 2, 6, 10, 12 and 14. Patients must have never had a T-cell count below 100. Viral load must be less than 50 copies/mL but must have been greater than 20,000 copies/mL at any time prior to starting the current HAART treatment. Patients must be between 18 and 45 years old. Pregnancy, alcohol/drug abuse, significant medical conditions, or use of hydroxyurea or immunomodulators within 12 weeks of study entry are not allowed. Please call Diane Schmidt of the Gladstone Institute of Virology and Immunology at (415) 695-3820.
T-20, an experimental new class of anti-HIV drug, has currently been studied using a specific formulation (carbonate). This study will test different doses of the carbonate formulation plus a new formulation (called tris) of T-20, to see if they are well-tolerated and to see how they are processed by the body. Hopefully, T-20 can be given with fewer injections and will still be effective in lowering the amount of HIV in the blood. Patients are randomized to one of four doses groups of T-20 to take with their background therapy (NRTIs, NNRTIs or protease inhibitors). Patients will switch doses of T-20 after 14 days and switch back to the original dose after 28 days. The dose differences will dictate how many injections per day patients must receive. On Days 14 and 28, patients will have all-day study visits for multiple blood tests. Study visits are once a month and the study lasts for 48 weeks or possibly longer. Patients must have at least 400 copies/mL of HIV RNA. Pregnancy, prior use of T-20, active alcohol/drug abuse and use of other experimental medications are not allowed. Please call Jay Lalezari, MD at Quest Clinical Research, San Francisco (415) 353-0800.
Pegylated Interferon
The purpose of this study is to see if pegylated interferon (a long-acting form of interferon) can lower the level of HIV in the blood of patients who have failed HAART and to see if pegylated interferon is well-tolerated. Patients will have genotype testing done at screening to see if there are any HAART drugs that are not likely to work against their particular virus. Patients are randomized to one of four doses of pegylated interferon (PEG Intron) or to receive a placebo. PEG Intron and its placebo are given by injection subcutaneously once a week. At Week 4, patients will change their HAART drugs based on the results of the genotype test done during screening. Study visits are once a week for the first month, then once a month thereafter. Patients will have another genotype test done at Week 28 to see if any changes have occurred after new HAART therapy and PEG Intron therapy have been given. The study lasts 32 weeks. Patients must have at least 200 CD4+ cells and at least 2,000 copies/mL of HIV RNA. Patients must be taking HAART for at least 16 months, and on the current HAART regimen for at least six weeks. Patients must have had a threefold viral load increase from the previous nadir in the last six months or a threefold increase from a previous low level of less than 500 copies/mL on the current HAART therapy. Pregnancy, active OIs, and interferon therapy within the last six months are not allowed. Please call Debbie Hildebrandt at ViRx, Inc. (415) 353-5623.
Thought You'd Like to Know . . .
California Academy of HIV Medicine Launched
The California Academy of HIV Medicine (CAHM) will be holding its founding membership meeting and dinner for HIV physicians in the West Bay region, which includes practices and clinics in Sonoma, Marin, San Francisco, San Mateo, Santa Clara, Santa Cruz and Monterey counties. The Academy is an organization of physicians dedicated to promoting excellence in HIV care.
On a national level, CAHM's parent organization, the American Academy of HIV Medicine, plans to be involved in the education and credentialing of HIV specialists. On a state level, CAHM will support quality care for patients with HIV.
There will be no charge to physicians for the dinner, which has been funded by a grant from Bristol-Myers Squibb, but please RSVP when you receive your invitation in the mail. For more information call Bill Owen, MD, at (415) 861-2400 or email Bill@owenmed.com.
About | Education & Information | Research | Membership | Contact | Search | Home
UCSF | Positive Health Program
3180 18th Street Suite 201 | San Francisco, CA 94110
tel (415) 476-9554 | fax (415) 476-6948
Copyright 1999-2000 University of California Regents. All Rights Reserved