Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
|ClinicalTrials.gov Identifier: NCT00006617|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 15, 2015
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues.
HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Abacavir sulfate Drug: Amprenavir Drug: Lamivudine Drug: Zidovudine||Not Applicable|
With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages, with a minimal contribution from lymphocytes. This study addresses whether there is a third reservoir such as the central nervous system. Additionally, the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs.
Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities. Laboratory tests to assess side effects and virologic and immunologic parameters, including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients, are determined. In a pharmacoeconomic component of this study, patients have interviews and complete questionnaires at 5 clinic visits.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD)|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006617
|United States, New York|
|Aaron Diamond AIDS Res Ctr|
|New York, New York, United States, 10016|
|Principal Investigator:||Martin Markowitz|