Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002451
• Other study ID #: 246U
• Secondary ID: 104-00
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 17, 2000
• Last updated: June 23, 2005

Study information

• Verified date: July 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
United States	Albany Med College	Albany	New York
United States	Univ of Miami School of Medicine	Miami	Florida
United States	SUNY at Stony Brook / Division of Infectious Diseases	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,