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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002362
Recruitment Status : Suspended
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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 Start Date : August 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002362

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United States, California
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, United States, 95814
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
United States, Florida
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
United States, Illinois
Northstar Med Clinic
Chicago, Illinois, United States, 60657
United States, New Jersey
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States, 08244
United States, New York
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, United States, 11030
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Houston Clinical Research Network
Houston, Texas, United States, 77006
Univ of Texas / Med School at Houston
Houston, Texas, United States, 77030
Univ of Texas Health Sciences Ctr
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Triangle Pharmaceuticals

Layout table for additonal information Identifier: NCT00002362     History of Changes
Other Study ID Numbers: 298B
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2000

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers