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

NCT ID: NCT00002362

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1999-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Abacavir sulfate

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Emtricitabine

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triangle Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Univ of Texas Health Sciences Ctr

San Antonio, Texas, United States

Site Status

Ctr for AIDS Research / Education and Service (CARES)

Sacramento, California, United States

Site Status

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Site Status

Gary Richmond MD

Fort Lauderdale, Florida, United States

Site Status

Northstar Med Clinic

Chicago, Illinois, United States

Site Status

South Jersey Infectious Diseases Inc

Somers Point, New Jersey, United States

Site Status

North Shore Univ Hosp / Div of Infectious Diseases

Manhasset, New York, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Houston Clinical Research Network

Houston, Texas, United States

Site Status

Univ of Texas / Med School at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FTC-301

Identifier Type: -

Identifier Source: secondary_id

298B

Identifier Type: -

Identifier Source: org_study_id