Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
HIV Protease Inhibitors
Indinavir
Protease Inhibitors
Ritonavir
Criteria
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.