Clinical trial NCT00002362: A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Dideoxynucleosides
Drug Therapy, Combination
Stavudine
Reverse Transcriptase Inhibitors
abacavir
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Ctr for AIDS Research / Education and Service (CARES)
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Fort Lauderdale
country: United States
facility: Gary Richmond MD
state: Florida
city: Chicago
country: United States
facility: Northstar Med Clinic
state: Illinois
city: Somers Point
country: United States
facility: South Jersey Infectious Diseases Inc
state: New Jersey
city: Manhasset
country: United States
facility: North Shore Univ Hosp / Div of Infectious Diseases
state: New York
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Houston
country: United States
facility: Univ of Texas / Med School at Houston
state: Texas
city: San Antonio
country: United States
facility: Univ of Texas Health Sciences Ctr
state: Texas
Study officials:
References: