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

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 been suspended.

Sponsored by:	Triangle Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002362

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 III

MedlinePlus related topics:

AIDS AIDS Medicines

ChemIDplus related topics:

Abacavir Abacavir sulfate Stavudine Efavirenz

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

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

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

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

Locations


United States, California
	San Francisco Veterans Administration Med Ctr
	San Francisco, California, United States, 94121
	Ctr for AIDS Research / Education and Service (CARES)
	Sacramento, California, United States, 95814

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
	Univ of Texas Health Sciences Ctr
	San Antonio, Texas, United States, 78284
	Houston Clinical Research Network
	Houston, Texas, United States, 77006
	Univ of Texas / Med School at Houston
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Triangle Pharmaceuticals

More Information

Study ID Numbers:	298B, FTC-301
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002362
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

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

Stavudine

Emtricitabine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Dideoxynucleosides

Abacavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008