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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
Est. completion date
Est. primary completion date
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


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, 

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