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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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002362
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 2000
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: Abacavir sulfate
Drug: Efavirenz
Drug: Emtricitabine
Drug: Stavudine
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:
Study Start Date: August 1999
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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002362

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002362     History of Changes
Other Study ID Numbers: 298B, FTC-301
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Abacavir
Emtricitabine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015