A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate (Drug); Efavirenz (Drug); Emtricitabine (Drug); Stavudine (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: Triangle Pharmaceuticals
Summary
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.
Clinical Details
Official title: A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
Study design: Treatment, Safety Study
Detailed description:
Patients are randomized to receive open-label emtricitabine or ABC in combination with
stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48.
Patients are followed for 48 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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).
Exclusion Criteria
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).
Locations and Contacts
San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States
Ctr for AIDS Research / Education and Service (CARES), Sacramento, California 95814, United States
Gary Richmond MD, Fort Lauderdale, Florida 33316, United States
Northstar Med Clinic, Chicago, Illinois 60657, United States
South Jersey Infectious Diseases Inc, Somers Point, New Jersey 08244, United States
North Shore Univ Hosp / Div of Infectious Diseases, Manhasset, New York 11030, United States
Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States
Univ of Texas Health Sciences Ctr, San Antonio, Texas 78284, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Univ of Texas / Med School at Houston, Houston, Texas 77030, United States
Additional Information
Starting date: August 1999
Last updated: June 23, 2005
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