A Phase II, Randomized, Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of > 1,000 Copiesml

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-05-21

300

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.

CONDITIONS

Brief Title

A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

Who Can Participate

Age: 13Years +

All Genders

Eligibility Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are over 13 years old (need consent of parent or guardian if under 18).
Are HIV-positive.
Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).
Agree to abstinence or use of effective birth control during the study.
Have been taking NFV for the past 12 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have a fever for 7 days or diarrhea for 30 days before study entry.
Have a history of peripheral neuropathy within 60 days of study entry.
Have hepatitis.
Have any malignancy (cancer) other than minimal Kaposi's sarcoma.
Are pregnant or breast-feeding.
Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.
Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.
Have received an HIV vaccine 30 days before study entry.
Are receiving certain other medications.