Safety and Effectiveness of Combining Hydroxyurea (HU) With Didanosine (ddI) and Stavudine (d4T) for Treatment of HIV-Infected Adults

Launched by RESEARCH INSTITUTE FOR GENETIC AND HUMAN THERAPY · Aug 30, 2001

Keywords

ClinConnect Summary

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 prio...

Gender

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Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are HIV-positive.
• • Have a viral load of 5,000 to 100,000 copies/ml.
• • Are willing to stop all anti-HIV medications for at least 28 days before receiving study drugs.
• • Are at least 18 years old.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Have a history of opportunistic (AIDS-related) infection.
• • Have a history of pancreatitis or other serious condition.
• • Have any cancer that will require chemotherapy within the next 24 weeks.
• • Are allergic to ddI or d4T.
• • Have received an HIV vaccine within 28 days of study entry.
• • Have received a red blood cell transfusion within the past 60 days, or have had repeated transfusions at any time in the past.
• • Abuse alcohol or drugs.
• • Have received certain medications.