Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults
- Conditions
- HIV Infections
- Registration Number
- NCT00002427
- Lead Sponsor
- Research Institute for Genetic and Human Therapy
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States
San Francisco VA Med Ctr
🇺🇸San Francisco, California, United States
Gary Blick MD
🇺🇸Stamford, Connecticut, United States
Dr Bruce Rashbaum
🇺🇸Washington, District of Columbia, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Boulevard Comprehensive Care Ctr
🇺🇸Jacksonville, Florida, United States
Center for Quality Care
🇺🇸Tampa, Florida, United States
AIDS Research Consortium of Atlanta Inc
🇺🇸Atlanta, Georgia, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Albany Med College
🇺🇸Albany, New York, United States
Scroll for more (8 remaining)AIDS Healthcare Foundation🇺🇸Los Angeles, California, United States