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
2 other identifiers
interventional
30
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, 60611, United States
Chase Braxton Health Service
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Albany Med College
Albany, New York, 12208, United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599, United States
The Research and Education Group
Portland, Oregon, 97210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2000-02