The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001
Trial Information
Current as of July 12, 2025
Completed
Keywords
ClinConnect Summary
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:
1. The observed proportion of patients with serum viral RNA \< 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 4...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Patients must have:
- • HIV-1 seropositive status.
- • CD4 count \>= 100 cells/mm3.
- • Serum viral RNA levels \>= 10,000 copies/ml.
- • Exclusion Criteria
- Prior Medication:
- Excluded:
- • Prior protease inhibitor therapy.
- • Prior non-nucleoside reverse transcriptase inhibitor therapy.
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
San Francisco, California, United States
Boston, Massachusetts, United States
Stony Brook, New York, United States
Providence, Rhode Island, United States
Honolulu, Hawaii, United States
Denver, Colorado, United States
Chicago, Illinois, United States
San Diego, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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