april 2000
Next Meeting: May 24, 2000
Report from the March
AIDS Clinical Grand Rounds
Structured Treatment Interruptions
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
Just Opened in the Bay Area
Effect of Chronic Alcohol Abuse on HIV CNS Progression
Antiretroviral Therapy: Indinavir, Ritonavir
HIV and Heart Disease: Dietary Intervention
Immunotherapy: Remune
Thought you'd like to know . . .
California Academy of HIV Medicine Launched
Syphilis Elimination Program Offered by City Clinic
Donald I. Abrams, MD, Editor
Next Meeting: Happy 15th Anniversary!
The April meeting of the Community Consortium is being cancelled due to a conflict with the Passover holiday. In contrast to what was reported in the last issue of Synopsis, the May meeting will feature our 15th anniversary celebration. It was March 1985 when the Community Consortium first convened. The special gala dinner, to be held on Wednesday, May 24th, will feature a brief discussion of "Community-based Clinical Trials: Past, Present and Future" by Donald Abrams, M.D.
The event will focus on celebrating the Consortium's first fifteen years of existence and its accomplishments. We hope the evening will provide an opportunity to rekindle old friendships and remember friends who are no longer with us. Further details of the festivities will be forthcoming in an official invitation to be mailed soon. AIDS Clinical Grand Rounds will resume in its regularly scheduled third Wednesday of the month time slot on June 21, in the auditorium (B level) at the Davies Campus of the California Pacific Medical Center. In the meantime, Happy Passover, Happy Easter and Happy 15th Anniversary!
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, nurse may obtain CEU credits but must keep a record of their own attendance. One hour of credit is available for this meeting.
Structured Treatment Interruptions
The March 2000 AIDS Clinical Grand Rounds featured a presentation on "Structured Treatment Interruptions" by Jody Lawrence, M.D., the newest faculty member of the UCSF Positive Health Program at San Francisco General Hospital. Dr. Lawrence is also the co-chair of the CPCRA's Multi-Drug Resistance (MDR) protocol, which incorporates a four-month structured treatment interruption (STI) into the trial design. Talk of STIs has been increasing exponentially both in patient and provider circles recently. Dr. Lawrence pointed out that STIs are being discussed in two different patient populations. The first are individuals with fully suppressed viral loads. Often these are patients with early infection or people who have recently begun HAART regimens. The idea of an STI in this situation is to "auto-vaccinate" the patient. A number of investigators have suggested that a low level of HIV viremia may be useful in stimulating the body's own immune response to the virus. Total suppression removes this stimulus to the immune system. Although cellular assays appear to be confirming the theory by showing a boost in cellular immune response directed against HIV, Dr. Lawrence believes that the jury is still out as to whether this translates into any clinical benefit.
The second group of patients in which STIs are being considered are more advanced HAART-experienced patients with virologic failure. Drugs are being stopped regardless of whether the virus is sensitive, resistant or highly resistant (MDR). Much of the impetus for STIs in these patients stems from studies conducted by Veronica Miller, Ph.D. from Frankfurt. Dr. Miller reported on findings of 39 individuals, exposed to at least two protease inhibitors for at least one year who were virologically failing their regimens. All patients discontinued their HAART regimens for two months. Samples were available for resistance testing before and after the STI in the 39 subjects. After eight weeks off therapy, 26 of the patients had a virus that reverted back to wild type. Their viruses had previously been resistant to a median of 8 drugs (range 2-11). The 13 patients whose viruses did not shift back to wild type had also been previously resistant to a median of 8 drugs (range 2-11). Viral load increased by 0.7 log and CD4+ cells fell an average of 89 cells/mm3 following the STI. Dr. Lawrence stressed that for most people discontinuing treatment, even if you think there has been no effect of the therapy, HIV RNA will increase at least 0.5 log and CD4+ cells will decline.
Miller analyzed the factors that appeared to be associated with the shift to wild type virus. The higher the patients' baseline CD4+ cell count at the time of the STI, the more likely their virus was to shift. Those patients whose virus shifted also had more of a drop in CD4+ cells during the STI. Upon re-initiation of HAART, viral load declined 2.80 log in those patients whose virus had reverted to wild type, compared to -1.02 log in those who did not. Eighteen of the 25 who shifted to wild type had HIV RNA levels < 500 copies within 24 weeks of resuming therapy, compared to only 2 of the 12 who did not revert. Correlates of reaching viral suppression to < 500 copies included baseline CD4+ (O.R. 1.26); baseline viral load (O.R. 0.56); shift to wild type virus (O.R. 3.69); and number of new drugs in the regimen (O.R. 1.42).
Dr. Lawrence summarized a small retrospective observational cohort conducted by Miller et al. All patients undergoing an STI experienced a rise in viral load and a drop in CD4+ cell counts, but two-thirds did revert to wild type virus. The shift to wild type was associated with a short-term virologic benefit on reinstitution of HAART therapy. Dr. Lawrence next turned to the data presented at the recent 7th Conference on Retroviruses and Opportunistic Infections by Steven Deeks, M.D. of the UCSF Positive Health Program at SFGH. Deeks and colleagues conducted a randomized trial in treatment experienced patients whose HIV RNA levels had been greater than 500 copies for at least one year, and had HIV RNA levels >2500 copies at study entry. Participants needed to be on a stable regimen and had to be willing to discontinue therapy. Individuals on hydroxyurea containing regimens were excluded.
Eighteen patients were randomized to undergo an STI. Baseline CD4+ cell count averaged 245/mm3 (range 104-307). Subjects had been on protease inhibitors for a mean of 36 months with 31 months of virologic failure. PI resistance was increased 56-fold at baseline as assessed by phenotypic resistance testing. After twelve weeks of STI, CD4+ cells declined an average of 94 cells/mm3 (-28 to -128) and viral load increased by 0.82 log (0.34-0.92). Virus reverted to wild type in 16 of 17 patients. The mean duration of time required for the reversion to wild type was 8.5 weeks (5.8-11). When resistance was lost, it was lost to all drugs at the same time. The question remains whether resistant virus actually reverts to wild type or whether the observed phenomenon is an overgrowth of persistent wild type virus. Dr. Lawrence suggested that current thinking favors the latter -- that mutant virus declines and wild type overgrowth ensues.
Deeks and colleagues also reported that the change in HIV RNA levels and CD4+ lymphocyte counts is much more marked following the reversion to predominantly wild type species. There is an initial mild decline in CD4+ cell counts when HAART is discontinued, followed by a plateau effect, and then an accelerated loss of cells after the reversion. It has been demonstrated that viral fitness increases following the shift. In evaluation of patient's peripheral blood mononuclear cells, Deeks and colleagues found that resistant virus was still there. When the drug pressure is removed, wild type virus returns because it is a more fit virus.
Dr. Lawrence went on to describe the design of CPCRA 064 -- the MDR protocol that will soon be launched nationwide. This will be a randomized clinical endpoint study designed 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 multi-drug resistant HIV. 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. She explained that whereas four months was selected as the duration of the STI, there is little existing information on the optimal amount of time to wait before resuming therapy. The first 150 participants in the CPCRA trial will have point mutation assays performed. These are more sensitive than routine resistance assays. They will also undergo more frequent HIV RNA testing, which should enable the investigators to know early in the course of the trial whether 4 months is too long or too short of an STI.
Four hundred and eighty subjects will be randomized in the trial over an anticipated 12-month accrual period. This will make this by far the largest of the STI trials conducted to date. Participants will be followed monthly for the first eight months and then every four 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 of 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 include age >13 years with HIV RNA > 10,000 copies/mL. The potential subject must have demonstrated a multi-drug resistant HIV strain on genotypic antiretroviral resistance testing (GART), with evidence of broad PI resistance combined with broad NNRTI and/or broad NRTI resistance patterns. 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 103N mutation or a combination of two other NNRTI mutations. Broad resistance to nucleosides is defined as the presence of 151M or 69S(XX) or a combination of mutations including the 215 Y/F mutation. Any patient previously exposed to 3 nucleosides, one NNRTI and 2 PIs is also eligible for screening and will have GART performed if they meet the remaining entry criteria.
A concern was expressed by a Consortium provider that patients with very low CD4+ cell counts and high viral loads who are otherwise clinically stable may be tempted or encouraged to participate in the trial. He was expressing the concern that as long as the patient is not progressing clinically, their regimen may be doing something that would be lost if they discontinued therapy. He suggested that the real question providers should be addressing is what is holding up new drugs in the pipeline so that people won't have to develop MDR viruses. In the meantime, it is becoming clear that increasing numbers of patients and providers are considering and advising STIs and the CPCRA study will provide a carefully controlled trial setting in which some of these questions can be answered. 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!
Committee Reports
The next meeting of the Community Consortium Executive Advisory Board will be held on Wednesday, May 31, 2000 at 7:30 a.m. in the Community Consortium Conference Room.
June 17 CME Program
The next Saturday CME program will be held on June 17, 2000 from 8:30 a.m. to 1:00 p.m. at the Davies Campus of California Pacific Medical Center. The meeting will provide an Update of Clinical Management of HIV-Related Conditions. Confirmed speakers at this time include Toby Maurer, M.D., Chief of Dermatology at San Francisco General Hospital, who will discuss management of dermatologic problems; and Cheryl Jay, M.D., Associate Clinical Professor of Neurology at UCSF, who will discuss neuropathy and HIV infection. Additional speakers are being sought to discuss treatment of depression, and to provide an update on treatment of hyperlipidemia, metabolic disturbances and body habitus alterations. This promises to be a most practical and informative session of our Saturday CME programs. Mark your calendars now and we'll see you there!
New HIV Clinical Trials Guide Available
Congratulations to David Townley for producing another outstanding edition of the Guide to HIV Clinical Trials in California. Community Consortium members should have received a copy this month. If not, contact the office at 415-476-5777 to request a mailing. The Spring 2000 edition contains 147 studies, including 41 new studies that have recently opened for enrollment. It also includes listings of all drugs covered by the California AIDS Drug Assistance Program, as well as all drugs available through industry-sponsored patient assistance programs. We appreciate the generous funding provided by Roche Laboratories, Inc. and Agouron Pharmaceuticals that allowed us to produce the current edition.
Treatment Information Binders Available
The Community Consortium's Treatment Information binders seem to be quite a success. This collection of reproducible patient information sheets on numerous drugs compiled by Community Consortium staff is proving to be very useful to Community Consortium providers who have requested them. We do appreciate the feedback and suggestions for additions, improvements, etc. If you missed the opportunity to request a binder, please FAX a request to the Community Consortium office at 415-476-6948.
Scientific Advisory Committee Community Advisory Board
The Scientific Advisory Committee (SAC) and Community Advisory Board (CAB) met on April 6 to discuss a number of projects in development. At the March meeting, Hank Wilson of ACT UP Golden Gate presented a concept sheet for an observational study of people choosing to experiment with a "structured treatment interruption," which Hank reported is becoming increasingly common. To assess the frequency of this phenomenon, Starley Shade, MPH, the Community Consortium's statistician, searched the various observational studies currently being conducted by the Community Consortium to determine the number of people who had interrupted their HAART for one month or more. Of 946 patients in the databases, 32 patients (4%) fit these criteria. For the next SAC/CAB meeting, Starley will present a more complete description of these patients in terms of their demographics, medical history and baseline characteristics, as well as some preliminary outcome data (e.g., CD4 change/month, log viral load change/month, clinical events, etc.). 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. To date the Consortium has enrolled 24 patients onto the trial that has accrued 560 nationwide. Congratulations and thanks to Robert Scott, MD in Oakland and Paula Pell, RN, MS, Community Consortium research nurse, for enrolling 13 patients onto this study. 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 measure- ments (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.
Protease Inhibitor Progression (PIP) The PIP protocol is closed to further enrollment. The Consortium was only able to enroll only four patients onto this trial, all of whom were enrolled by Harry Lampiris, M.D. at the SFVAMC, and Sherrill Crawford, RN, Consortium research nurse. Due to low accrual nationally, the protocol is closed to new enrollments. The CPCRA will be working to develop a more strategic trial for individuals with early progression that focuses on on how to change and when to change therapy. The protocol team is evaluating how best to follow subjects currently enrolled on PIP.
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 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. 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.
Sixty-five patients have now been enrolled and randomized in the Consortium study of short-term effects of cannabinoids in patients with HIV infection. The target sample size increased to 67 because some patients dropped out of the protocol prior to reaching the critical Day 14 evaluations. However, only two more participants are needed to complete the trial! We hope that the study will be ready for analysis by June. Thanks to all of you who referred participants to this important study. A tremendous dose of kudos to Community Consortium Study Coordinator Roz Leiser, RN, who has brilliantly coordinated the trial and the recruitment of patients since it?s inception 30 months ago!
Just Opened in the Bay Area Effect of Chronic Alcohol Abuse on HIV CNS Progression Harry Lampiris, M.D., of the San Francisco VAMC presented information on a new study launched by the CNS Group Cognitive Neuroscience at the UCSF/VA Medical Center. The goal of the study is to study the effects of chronic heavy alcohol use and HIV disease on the brain. The study is NIH funded. The goal is also to evaluate how alcohol use effects the efficacy of protease inhibitors. Participants undergo a structured clinical interview, a Center for AIDS Prevention Studies (CAPS) interview and cognitive testing. An EEG and MRI are also part of the evaluation. If you have patients who may be eligible to participate in this trial, please contact the CNS Group at 415-221-4810, ext 3081. Antiretroviral Therapy: Indinavir, Ritonavir This study will look to see if indinavir with ritonavir plus two NRTIs can return the viral load to less than 400 copies after virologic failure while taking a combination which included indinavir or nelfinavir. All patients will take indinavir and ritonavir twice a day plus either two new NRTIs or one new NRTI plus one NRTI that has not shown evidence of viral resistance. The NRTIs are not provided by the study and should be obtained by prescription or by other means. Study visits are once a month and the study lasts six months. Patients must have at least 50 CD4 cells and between 400 and 20,000 copies/mL of HIV RNA. Patients must be on antiretroviral therapy that contains indinavir or nelfinavir for at least 16 weeks and be on that treatment at study entry. Patients must have had an initial response to this treatment showing two viral load levels less than 400 copies/mL followed by at least two measurements of between 400 and 20,000 copies/mL. Pregnancy, more than seven days use of any two protease inhibitors at the same time, and patients in whom no new NRTI therapy is possible are not allowed. Call Steve Collinson, RN at the Institute for HIV Research at California Pacific Medical Center - Davies Campus (415- 600-6660) Merck. HIV and Heart Disease: Dietary Intervention The purpose of this study is to see if certain foods can cause changes in body fat distribution and decrease risk factors for heart disease in HIV positive individuals. Potential patients will spend two days at the General Clinical Research Center (GCRC) at San Francisco General Hospital to determine if they qualify for the diet intervention. Eligible patients are then readmitted for two more weeks to consume the second diet. Tests will be conducted at the end of each diet period to determine if the diets decreased risk factors for heart disease. The study lasts six weeks. Patients will be paid for their participation in this study. Patients must be 18 years old and on stable medications for at least three months prior to study entry. Pregnancy, past diabetes, kidney or liver diseases, prior use of interferon, severe diarrhea and current use of carbohydrate or lipid-lowering drugs are not allowed. Call Alan Rosen of the Division of Gastroenterology at San Francisco General Hospital (415-206-4771). This study will see if Remune together with antiretroviral medications can keep the level of HIV virus in the blood low for a longer period of time than with antiretroviral medications alone. Patients are randomized to add Remune or Remune placebo to their current antiretroviral medications. Remune and its placebo are given by injection into a muscle at the beginning of the study and every 12 weeks thereafter. Neither patients nor providers will know which they are receiving until the study ends. Antiretroviral medications are not provided by the study and should be obtained by prescription or by other means. Patients experiencing a virologic relapse (viral load > 2,000 copies/mL) will be encouraged to switch to a new drug combination. Study visits are every 12 weeks and patients will be in this study until the last patient to enroll has completed 96 weeks of treatment. Patients must have at least 300 CD4 cells and have less than 500 copies of HIV RNA for at least 12 weeks prior to study entry. Patients must be on a stable antiretroviral regimen for at least 12 weeks prior to study entry. Pregnancy, acute infections, cancers requiring chemotherapy, prior radiation treatment of the lymph nodes, or prior use of HIV vaccines is not allowed. Call Marc Gould of the Positive Health Practice at San Francisco General Hospital (415-514-0550 ext. 362) or Joann Volinski of the Marin County Specialty Clinic (415-499-7377) ACTG A5057.
Thought you'd like to know . . .
California Academy of HIV Medicine Launched The California Academy of HIV Medicine (CAHM) held its founding membership meeting 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. For more information call Bill Owen, MD, at (415) 861-2400 or email Bill@owenmed.com.
Syphilis Elimination Program Offered by City Clinic A reminder to all San Francisco clinicians that City Clinic offers a variety of services to medical professionals as part of their syphilis elimination program funded by the U.S. Centers for Disease Control and Prevention. Services include consultation for syphilis staging, partner tracing, visual aids, and educational materials. They also cover topics such as other STDs and work in various communities throughout the city to ensure continued access to care and awareness with regard to STDs. The following staff are contact persons for their respective areas of expertise: For medical questions relating to diagnosis, staging and treatment of syphilis, please call Joe Engleman at 415/487-5595 or page him at 415/207-0196. To report syphilis cases, please call Bart Bartolini at the reactor desk, 415/487-5531 or Veronica Davila at 487-5517.
Barry Freehill, also a community member, presented a concept sheet at the March SAC/CAB for a randomized, controlled trial to determine if continuing 3TC when switching to a new HAART regimen in patients with the M184V mutation is associated with a slower rate of development of resistance and virologic failure as compared to not continuing 3TC when switching to a new HAART regimen. At the April SAC/CAB meeting, Starley Shade presented data from our observational databases that indicated that 781 of the 946 patients in these studies had ever been on HAART. Of these patients, 153 had stopped or changed their PI or NNRTI during study follow-up. Of these 153 patients, 45 had stopped 3TC and 39 had continued 3TC. We don't yet collect genotypic resistance data in the observational studies, so we are not able to determine which of these patients had the M184V mutation. We are now assessing the feasibility of collecting those data.
The next SAC/CAB meeting will be held on Thursday, May 4, 2000 at 12 noon in the Community Consortium conference room. Lunch will be provided. We are continuing to work on developing the STI observational database and additional trials that the Community Consortium may undertake. We need your input. Come join us at this important SAC/CAB meeting and let your voice be heard!
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.
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