HIV Infections Clinical Trial
Official title:
A Phase I/II Study of the Safety and Antiretroviral Activity of Nine Hydroxyurea Regimens in Combination With ddI and d4T in Subjects With HIV Infection
The purpose of this study is to compare the safety and effectiveness of 9 doses of HU in
order to find the best dose of HU to use with ddI and d4T in fighting HIV infection.
HU plus ddI plus d4T appears to be a suitable anti-HIV drug combination for long-term
control of HIV. This combination can sharply decrease viral load (level of HIV in the body)
with few side effects, making it easy to take.
The combination of HU plus ddI plus d4T appears to be suitable for long-term control of HIV
in that it: (1) has a novel resistance/rebound profile demonstrating virus suppression even
in the presence of ddI-resistant mutants; (2) can produce a pronounced fall in viral load;
and (3) is well tolerated (over 200 patients have been treated for up to 3 years with
minimal side effects).
Patients are stratified by antiretroviral experience: naive (no more than 2 weeks of
therapy) versus experienced (more than 2 weeks). Patients must discontinue all
antiretroviral therapy for at least 28 days prior to randomization to 1 of 9 HU treatment
arms. Treatment arms are divided into 3 HU dose categories: very low, low, and medium.
Within each category HU is administered daily on 3 different dosing schedules. Depending on
viral load, patients on the very low and low dose arms may have the opportunity to intensify
their HU dose at any time beyond Week 12, provided no Grade 3 or 4 HU-related toxicity is
present (these patients are monitored for an additional 8 weeks following intensification).
All patients receive ddI and d4T at the same doses every day. When 50% of patients have
completed 24 weeks of treatment, an analysis is made to determine whether or not to continue
the 52-week study without modifications. Patients are monitored periodically for changes in
plasma HIV RNA, CD4 cell counts, weight, and symptoms.
;
Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Primary Purpose: Treatment
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