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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	August 1999
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title ^ICMJE	A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
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.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Abacavir sulfate Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002362
Responsible Party
Study ID Numbers ^ICMJE	298B, FTC-301
Study Sponsor ^ICMJE	Triangle Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP