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

COMPLETEDPHASE2

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

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

NCT00002361•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (8)

LAC / USC Med Ctr / Infectious Diseases

Los Angeles, California, United States

Univ of Miami School of Medicine

Miami, Florida, United States

Northwestern Univ / Div of Infect Diseases

Chicago, Illinois, United States

Chase Braxton Health Service

Baltimore, Maryland, United States

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Albany Med College

Albany, New York, United States

Univ of North Carolina / Infectious Disease Division

Chapel Hill, North Carolina, United States

The Research and Education Group

Portland, Oregon, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Indinavir sulfate

DRUG

Ritonavir

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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