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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002361

Run by

Merck Sharp & Dohme LLC

People needed

30

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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