HIV Infections Clinical Trial
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)
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.
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.
;
Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
| Completed |
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Phase 2 |