- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002362
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
June 23, 2005 updated by: Triangle Pharmaceuticals
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Sacramento, California, United States, 95814
- Ctr for AIDS Research / Education and Service (CARES)
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San Francisco, California, United States, 94121
- San Francisco Veterans Administration Med Ctr
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Gary Richmond MD
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Illinois
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Chicago, Illinois, United States, 60657
- Northstar Med Clinic
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New Jersey
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Somers Point, New Jersey, United States, 08244
- South Jersey Infectious Diseases Inc
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New York
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Manhasset, New York, United States, 11030
- North Shore Univ Hosp / Div of Infectious Diseases
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Texas
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Dallas, Texas, United States, 75235
- Univ of Texas Southwestern Med Ctr of Dallas
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Houston, Texas, United States, 77006
- Houston Clinical Research Network
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Houston, Texas, United States, 77030
- Univ of Texas / Med School at Houston
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San Antonio, Texas, United States, 78284
- Univ of Texas Health Sciences Ctr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1999
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
March 1, 2000
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Emtricitabine
- Stavudine
- Efavirenz
- Abacavir
Other Study ID Numbers
- 298B
- FTC-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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