A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
2 other identifiers
interventional
N/A
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
March 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, 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
Houston Clinical Research Network
Houston, Texas, 77006, United States
Univ of Texas / Med School at Houston
Houston, Texas, 77030, United States
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
August 1, 1999
Last Updated
June 24, 2005
Record last verified: 2000-03