A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Key facts

Study ID

NCT00004581

Run by

Abbott

People needed

300

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…

• Patients may be eligible for this study if they:
• Are at least 12 years old.
• Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
• Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
• Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
• Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have an active illness.
• Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
• Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
• Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
• Have received treatment with a PI other than their current PI.
• Are receiving chemotherapy for cancer.
• Are pregnant or breast-feeding.

Where it is running

• Phoenix Body Positive — Phoenix, Arizona, United States
• Pacific Oaks Med Group — Beverly Hills, California, United States
• 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
• 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
• Cook County Hosp — Chicago, Illinois, 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
• Saint Michael's Med Ctr / Dept of Infectious Diseases — Newark, New Jersey, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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