Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments indinavir sulfate, ritonavir, lamivudine, stavudine
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Trial size 8 participants
Trial identifier NCT00002451, 104-00, 246U

Summary

The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by NIH AIDS Clinical Trials Information Service.