Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001
Trial Information
Current as of July 04, 2025
Unknown status
Keywords
ClinConnect Summary
Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients may be eligible for this study if they:
- • Are HIV-positive.
- • Are at least 18 years old.
- • Have a viral load of 5,000 copies/ml or greater.
- • Have a CD4 count of at least 50 cells/mm3.
- • Exclusion Criteria
- Patients will not be eligible for this study if they:
- • Have taken any antiretroviral (anti-HIV) agent.
- • Are pregnant.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Albany, New York, United States
Stony Brook, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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