Overview

A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV). Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Abbott
Treatments:
Lamivudine
Lopinavir
Nelfinavir
Ritonavir
Stavudine
Criteria
Inclusion Criteria

You may be eligible for this trial if you:

- Are HIV positive.

- Have a viral load (level of HIV in your blood) of more than 400 copies/ml.

- Are age 12 or older.

- Agree to practice abstinence or use effective methods of birth control during the
study.

Exclusion Criteria

You will not be eligible for this trial if you:

- Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken
d4T or 3TC.

- Are seriously ill or have an AIDS-related infection.

- Are pregnant or breast-feeding.

- Are taking certain medications.