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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004583

Run by

Abbott

People needed

660

Starts

1999-03-01

Last updated by the study team

2009-02-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orange County Ctr for Special Immunology — Fountain Valley, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Tower ID Med Associates — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Yale Univ / AIDS Clinical Trials Unit — New Haven, Connecticut, United States
• Steinhart Medical Associates — Miami, Florida, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Infectious Disease Research Institute — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Emory Univ — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Tulane Univ Med School — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Boston Med Ctr — Boston, Massachusetts, United States
• Community Research Initiative of New England — Brookline, Massachusetts, United States
• Univ of Michigan Hospitals and Health Ctrs — Ann Arbor, Michigan, United States
• Abbott Northwestern Hosp — Minneapolis, Minnesota, United States
• East Orange Veterans Administration Med Ctr — East Orange, New Jersey, United States
• Beth Israel Med Ctr — New York, New York, United States
• Cornell Clinical Trials Unit - Chelsea Clinic — New York, New York, United States
• Pacific Oaks Med Group — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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