Clinical trial NCT00002195: A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
Official title: A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

Detailed description: This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-positive status.
* Screening viral load \>= 10,000 copies/mm3 14 days prior to entry.
* CD4+ cell counts \>= 200 cells/mm3 14 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinical diagnosis of AIDS (CDC 1993 Classification C).

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.

Patients with the following prior conditions are excluded:

Clinically relevant hepatitis in the previous 6 months.

Prior Medication:

Excluded:

* Greater than 4 weeks of any nucleoside antiretroviral therapy.
* Previous therapy with an HIV protease inhibitor.
* Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
* Immunomodulating agents within 3 months prior to entry.

Prior Treatment:

Excluded:

Radiotherapy within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Washington
country: United States
facility: Dr Bruce Rashbaum
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative of South Florida
state: Florida
city: Maitland
country: United States
facility: Community Research Initiative of Central Florida
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: New York
country: United States
facility: Saint Vincent's AIDS Ctr
state: New York
city: Memphis
country: United States
facility: Methodist Hosp
state: Tennessee
Study officials:
References: