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Search / Trial NCT00002387

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

Acquired Immunodeficiency Syndrome Drug Administration Schedule Hiv Protease Inhibitors Indinavir Reverse Transcriptase Inhibitors Anti Hiv Agents Efavirenz

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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