CLOSED RESEARCH STUDIES

COMPLETED RESEARCH STUDIES

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The following studies are closed to accrual, however patients on-study are in followup.

CC 029/CPCRA 036: A randomized study of the clinical effects of initiating or changing antiretroviral therapy based on plasma HIV RNA quantitation compared with initiating or changing therapy based on current clinical practice alone

Purpose: To determine whether using plasma HIV RNA quantitation, in addition to current clinical practice, in deciding when to initiate or change antiretroviral therapy confers clinical benefit or harm when compared with initiating or changing antiretroviral therapy based on current clinical practice alone.

Status: Patients are off-study

CC 033/CPCRA 039: A phase III, randomized, double-blind, placebo-controlled study of the safety and efficacy of adefovir dipivoxil (bis-POM PMEA) in prolonging survival of HIV-infected individuals with a CD4+ cell count of < 100/mm3 or with a CD4+ cell count of both >100 mm3 and <200/mm3 and a nadir CD4+ cell count of < 50/mm3.

Status: Patients are off study.

CC 034/CPCRA 042: A randomized trial of the efficacy and safety of a strategy of starting with nelfinavir versus ritonavir added to background antiretroviral reverse transcriptase inhibitor therapy in HIV-infected individuals with CD4+ cell counts less than or equal to 200/mm3

Purpose: The purpose of this study is to compare two antiretroviral (AR) treatment strategies, one starting with combination therapy including nelfinavir (NFV) and the other starting with combination therapy including ritonavir (RTV), in delaying disease progression, including death, in patients with CD4+ cell counts less than or equal to 200/mm 3.

CC 042/CPCRA 045: A prospective evaluation of HIV-1 genotypic resistance, viral load, and CD4+ count in HIV-infected individuals with CD4+ cell counts <200 mm3: A Substudy of CPCRA 042

Purpose: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts less than or equal to 200/mm3 who are enrolled in CPCRA 042.

CC 040/CPCRA 048: A randomized, double-blind, placebo-controlled trial of prophylaxis for disseminated Mycobacterium avium complex disease and bacterial pneumonia versus deferred prophylaxis in HIV-infected patients who experience rebound in CD4+ cell count due to active antiretroviral therapy

Purpose: To determine whether patients with HIV infection who experience significant recovery of their absolute CD4+ cell counts (i.e., from < 50 cells/mm3 to > 100 cells/mm3) following active antiretroviral therapy should receive prophylaxis for Mycobacterium avium complex (MAC) and bacterial pneumonia.

CC 043/CPCRA 059: A randomized, open-label, study of the impact of two doses of subcutaneous recombinant IL-2 (Proleukin ®) on viral burden and CD4+ cell count in patients with HIV-1 infection and CD4+ cell counts greater than or equal to 300/mm3

Purpose: The purpose of this study is to compare the effects of two doses of subcutaneous (SC) recombinant IL-2 (rIL-2) and no rIL-2 on HIV viral burden and CD4+ cell count in patients with HIV-1 infection and absolute CD4+ cell counts of greater than or equal to 300/mm 3. Study participants will be either currently receiving or initiating antiretroviral treatment prior to randomization. If the international phase III clinical endpoint trial of SC rIL-2 is implemented, patients enrolled in this CPCRA study will be strongly encouraged to enroll and receive continued treatment and followup in the international study.

Status: Patients have been rolled over to ESPRIT.

CC 045:CC-OCS: A Prospective, Longitudinal, Community-Based Observational Study of HIV-Infected Individuals

Purpose: The purpose of this study is to describe the short and long-term laboratory and clinical outcomes of patients receiving HIV care at Community Consortium-affiliated, community-based collaborative primary care sites in the San Francisco Bay Area.

For more information on this study please contact: Starley Shade, 415-476-9554x326, sshade@php.ucsf.edu

CC 047: DHEA: Dehydroepiandrosterone (DHEA) Effects on HIV-1 Replication and Host Immunity: A Randomized Placebo-Controlled Pilot Study

Purpose: The purpose of this study is to investigate how DHEA impacts on latent HIV-1 replication and host immunity by conducting a randomized, placebo-controlled study in patients with surpressed plasma viremia (>200 copies/mL).

For more information on this study please contact: Paul Couey, 415-476-9554x315, pcouey@php.ucsf.edu

CC 054: Distant Healing : Study of the Effect of Distant Healing Efforts by "Healers" and by Nurses in Advanced AIDS

Purpose: This study will investigate whether distant healing effort by experienced healers will provide real physical or psychological benefits to individuals living with AIDS.

For more information on this study please contact: Paul Couey, 415-476-9554x315, pcouey@php.ucsf.edu

CPCRA 058: FIRST : A Randomized, Open-Label Study of the Long-Term Effectiveness of Three Initial Highly Active Antiretroviral Therapy (HAART) Strategies in HAART-Naive, HIV-Infected Persons

Purpose: The purpose of the FIRST (Flexible Initial Retrovirus Suppressive Therapies) study is to determine whether it is better to start antiretroviral (AR) treatment with a protease inhibitor (PI) -containing regimen, a nonnucleoside reverse transcriptase inhibitor (NNRTI)-containing regimen, or a PI plus NNRTI-containing regimen in PI- and NNRTI-naive, HIV-infected individuals.

Status: This study is closed to accrual. Patients will continue to be monitored for follow-up.
FIRST - Executive Summary February 2006

CPCRA 060: LTM : A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals

Purpose: The Long-Term Monitoring study is designed to provide a mechanism for long-term follow-up of patients currently or previously enrolled in selected CPCRA HIV treatment or management protocols as well as antiretroviral-naive patients electing to defer treatment or to start it outside a CPCRA trial.

CPCRA 061: Metabolic : Metabolic Consequences of Highly Active Antiretroviral Therapy (HAART) in HIV-Positive Individuals

Purpose: The purpose of the Metabolic Protocol is to compare the randomized highly active antiretroviral therapy (HAART) strategy groups in the FIRST Protocol (CPCRA 058) for changes in total cholesterol, triglycerides, waist circumference, and waist-to-hip (circumference) ratio.

Status: This study is closed to accrual. Patients will continue to be monitored for follow-up.
Metabolic Executive Summary February 24, 2006

CPCRA 062: ADHERENCE : Adherence Startegies Using a Medication Manager And An Electronic Medication Reminder System For HIV-Infected Patients receiving HAART

Purpose:The primary purpose of this study is to evaluate the effects of two adherence interventions in a 2 x 2 factorial design: (1) the presence of of medication manager versus the absence of a medication manager and (2) the presence of an electronic medication reminder system versus the absence of an electronic medication reminder system on the durability of supression of the HIV RNA level among antiretroviral (AR)-naive, and AR-experienced patients enrolling into a qualifying CPCRA AR therapeutic protocol.

Status: This study is closed to accrual. Patients will continue to be monitored for follow-up.
CPCRA Abstract on Adherence: published January 2005

CPCRA 064: MDR : A Randomized Study of a Prescribed 4-Month Structured Treatment Interruption (STI) Followed by Initiation of a New Antiretroviral Regimen Versus Immediate Initiation of a New Antiretroviral Regimen in HIV-Infected Patients with Multidrug Resistant (MDR) Virus

Purpose: The purpose of the MDR-HIV study is to determine, for HIV-infected patients with genotypic evidence of multidrug resistant (MDR) virus, whether a prescribed 4-month structured treatment interruption (STI) followed by initiating a new antiretroviral drug regimen based on genotypic antiretroviral resistance testing (GART) and phenotypic antiretroviral resistance testing (PART) delays clinical disease progressiona nd death compared with a strategy of immediately initiaing a new antiretroviral drug regimen based on GART and PART.

Status: This study is closed to accrual. Patients will continue to be monitored for follow-up. New England Journal Of Medicine article (Lawrence)
New England Journal Of Medicine article (Hirschel)
Final Study Results (J. Lawrence)

CPCRA 065: SMART: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy

Purpose:The purpose of this study is to compare the long-term clinical consequences of two strategies of antiretroviral (AR) management:(1) the drug conservation (DC) strategy versus (2) a viral suppression (VS) strategy.

For more information on this study please contact: Pierre Crouch, 415-476-9554x333, pcrouch@php.ucsf.edu


Click here to view the SMART DSMB Summary, dated November 12, 2004

SMART DSMB Summary

SMART Protocol Letter re: MDR

CPCRA 065F: SMART : Neurology: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART) to Determine the Impact of the Strategies upon Central and Peripheral Nervous System Function

Purpose:This substudy will compare how the two ways of treating HIV disease (WAIT and GO groups) in the SMART study may affect nerve and brain function. HIV and some of the anti-HIV medicines may affect the nerves that run through the arms and legs.

CPCRA 065G: SMART : Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART)

Purpose:The purpose of the Anal Dysplasia Substudy is to compare the development of anal dysplasia or anal cancer between the GO (use anti-HIV drugs at all times to keep the viral load (amount of virus in the blood) as low as possible) and WAIT(wait to use anti-HIV drugs while a patient's chance of getting sick from HIV infection is low, based on his/her CD4 cell count) groups of the main SMART Study.

CPCRA 066: GENOMICS: Collection and Use of Blood For Genetic and Other Related Analyses

Purpose:The purpose of this study is to obtain a whole blood sample to archive for use in future studies investigating associations between human genetic factors and clinical data collected in qualifying CPCRA studies for the purpose of addressing questions related to HIV-infection or conditions relevant to the health of persons with HIV-infection.

Antihyperlipidemic Effects of Oyster Mushrooms in Persons with HIV Who Are Taking Kaletra: A Single-Arm, Open-Label, "Proof of Concept" Pilot Study

Purpose: Our primary goal is to evaluate the short-term safety and potential efficacy of oyster mushrooms (Pleurotus ostreatus) for treatment of hyperlipidemia in HIV-infected patients who are taking low-dose ritonavir and another protease inhibitor (PI), which is a common combination in highly active antiretroviral therapy (HAART) regimens.

CMCR: The Effect of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo Controlled Study

Purpose: The purpose is to evaluate the safety and effectiveness of smoked marijuana to treat pain caused by HIV-1 related peripheral neuropathy.

For more information on this study please contact: Hector Vizoso, 415-476-9554x321, hvizoso@php.ucsf.edu

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