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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00002362
• Other study ID #: 298B
• Secondary ID: FTC-301
• Status: Suspended
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: August 1999

Study information

• Verified date: March 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

• Efavirenz

• Emtricitabine

• Stavudine

Locations

Country	Name	City	State
United States	Northstar Med Clinic	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	Houston Clinical Research Network	Houston	Texas
United States	Univ of Texas / Med School at Houston	Houston	Texas
United States	North Shore Univ Hosp / Div of Infectious Diseases	Manhasset	New York
United States	Ctr for AIDS Research / Education and Service (CARES)	Sacramento	California
United States	Univ of Texas Health Sciences Ctr	San Antonio	Texas
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	South Jersey Infectious Diseases Inc	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Triangle Pharmaceuticals

Country where clinical trial is conducted

United States,