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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

Phase 2
Completed
Conditions
HIV Infections
Registration Number
NCT00002361
Lead Sponsor
Merck Sharp & Dohme LLC
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (8)

LAC / USC Med Ctr / Infectious Diseases

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Univ of Miami School of Medicine

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

Northwestern Univ / Div of Infect Diseases

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

Chase Braxton Health Service

πŸ‡ΊπŸ‡Έ

Baltimore, Maryland, United States

Beth Israel Deaconess Med Ctr

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Albany Med College

πŸ‡ΊπŸ‡Έ

Albany, New York, United States

Univ of North Carolina / Infectious Disease Division

πŸ‡ΊπŸ‡Έ

Chapel Hill, North Carolina, United States

The Research and Education Group

πŸ‡ΊπŸ‡Έ

Portland, Oregon, United States

LAC / USC Med Ctr / Infectious Diseases
πŸ‡ΊπŸ‡ΈLos Angeles, California, United States

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