A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Paused · Phase 3

Conditions studied: HIV Infections

In brief

This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.

Key facts

Study ID

NCT00002362

Run by

Triangle Pharmaceuticals

Starts

1999-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• You may be eligible if you:
• Are HIV-positive and generally healthy.
• Have a viral load of 5,000 copies/ml or more.
• Have CD4 cell counts of 200 cells/mm3 or more.
• Are age 18 or older.
• Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).

You may not qualify if…

• You will not be eligible if you:
• Have ever taken anti-HIV drugs for 3 days or more.
• Have had certain AIDS-related infections.
• Have had severe diarrhea within the past 30 days.
• Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.
• Are being treated for active tuberculosis (TB).
• Are pregnant or breast-feeding.
• Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments.
• Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).

Where it is running

• Ctr for AIDS Research / Education and Service (CARES) — Sacramento, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• Gary Richmond MD — Fort Lauderdale, Florida, United States
• Northstar Med Clinic — Chicago, Illinois, United States
• South Jersey Infectious Diseases Inc — Somers Point, New Jersey, United States
• North Shore Univ Hosp / Div of Infectious Diseases — Manhasset, New York, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Houston Clinical Research Network — Houston, Texas, United States
• Univ of Texas / Med School at Houston — Houston, Texas, United States
• Univ of Texas Health Sciences Ctr — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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