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 80 participants
Trial identifier NCT00002241, 094-00, 246T, CRX463

Summary

The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.

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 16 years old.

Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more. - Are age 16 or older (consent of a parent or guardian required if under 18). - Agree to practice abstinence or use barrier methods of birth control (such as condoms). - Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.) Exclusion Criteria Patients will not be eligible for this study if they: - Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed). - Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV). - Have changed their medications in the last 2 weeks. - Are allergic to IDV, RTV, d4T, or 3TC. - Have used certain medications (see the technical summary for more detail). - Are pregnant or breast-feeding.

Additional Information

Official title A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
Description Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
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.