Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease Inhibitors

HIV Infections Clinical Trial

Official title:

A Multicenter, Open-Label, 24-Week Study to Evaluate the Safety and Activity of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 200 Mg b.i.d. and Two NRTIs in HIV-1 Infected Patients Who Failed PI Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002361
• Other study ID #: 246S
• Secondary ID: 088-00
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 2000
• 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 and effective to give an anti-HIV drug combination containing indinavir and ritonavir to HIV-positive patients who have failed previous treatment with protease inhibitors.

Description:

Patients receive indinavir and ritonavir twice daily plus 2 NRTIs (NRTIs are not provided by this study). Physical examinations and laboratory tests, including plasma viral RNA levels and CD4 cell counts, are performed at Day 1 and Weeks 4, 8, 12, 16, 20, and 24 (or at discontinuation). The incidence of serious and drug-related adverse experiences is tabulated to determine drug safety. The proportion of patients achieving plasma viral RNA levels below 50 copies/ml (by UltraSensitive assay) are estimated statistically to determine drug efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have a viral load (level of HIV in the blood) of 2500 copies/ml or greater within 45 days of study entry.

• Have a CD4 cell count of 100 cells/mm3 or greater within 45 days of study entry.

• Have been on an anti-HIV drug regimen containing a protease inhibitor for at least 16 weeks and initially did well on this treatment (your viral load decreased significantly) but later experienced treatment failure on this drug combination (your viral load increased significantly).

• Experienced treatment failure within 24 weeks of study entry.

• Are 18 years of age or older.

• Agree to use effective barrier methods of birth control (such as condoms) during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Are allergic to ritonavir or indinavir.

• Have hepatitis.

• Have an abnormal chest x-ray or abnormal liver function tests.

• Have taken 2 protease inhibitors at the same time for 7 or more days.

• Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) in the 2 weeks before study entry.

• Have a medical condition that might make it unsafe for you to take the study drugs.

• Have experienced resistance to NRTIs and no new NRTI therapy is possible.

• Have taken certain medications.

• Abuse alcohol or drugs.

• Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

Locations

Country	Name	City	State
United States	Albany Med College	Albany	New York
United States	Chase Braxton Health Service	Baltimore	Maryland
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Univ of North Carolina / Infectious Disease Division	Chapel Hill	North Carolina
United States	Northwestern Univ / Div of Infect Diseases	Chicago	Illinois
United States	LAC / USC Med Ctr / Infectious Diseases	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	The Research and Education Group	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States,