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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000918

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Expected to finish

2002-02-01

Last updated by the study team

2012-05-21

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Willow Clinic — Menlo Park, California, United States
• San Francisco AIDS Clinic / San Francisco Gen Hosp — San Francisco, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
• Marin County Specialty Clinic — San Rafael, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Emory Univ — Atlanta, Georgia, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Harvard (Massachusetts Gen Hosp) — Boston, Massachusetts, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• SUNY / Erie County Med Ctr at Buffalo — Buffalo, New York, United States
• Beth Israel Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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