Clinical trial NCT00008554: Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
Official title: A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 210
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

Detailed description: Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 13 years old (consent of parent or guardian required if under 18).
* Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
* Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
* Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
* Have an active/acute CDC Category C event.
* Are unable to absorb or take medicines by mouth.
* Are pregnant or breast-feeding.
* Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
* Have had pancreatitis or hepatitis within the last 6 months.
* Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
* Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
* Have received HIV vaccine within 3 months before the study drug will be taken.
* Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
* Have received experimental treatments.
* Have allergies which might interfere with the study, in the opinion of the doctor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: East Bay Clinical Trial Ctr
state: California
city: Long Beach
country: United States
facility: Ocean View Internal Medicine
state: California
city: Orlando
country: United States
facility: Florida ID Group
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Tampa
country: United States
facility: Clinical Pharmacology Services
state: Florida
city: Chicago
country: United States
facility: Veterans Affairs Med Ctr of North Chicago
state: Illinois
city: Kansas City
country: United States
facility: Univ of Kansas Med Ctr
state: Kansas
city: Newark
country: United States
facility: Saint Michael's Med Ctr
state: New Jersey
city: Newark
country: United States
facility: UMDNJ - New Jersey Med School
state: New Jersey
city: Bronx
country: United States
facility: Bronx Municipal Hosp Ctr/Jacobi Med Ctr
state: New York
city: Brooklyn
country: United States
facility: Addiction Research and Treatment Corp
state: New York
city: Brooklyn
country: United States
facility: Brookdale Univ Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Gervais Frechette
state: New York
city: New York
country: United States
facility: Howard Grossman
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
city: Charlotte
country: United States
facility: SMO-USA Inc
state: North Carolina
city: Eugene
country: United States
facility: Advanced Clinical Trials Inc
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ
state: Pennsylvania
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: MacGregor Med Association
state: Texas
city: Irving
country: United States
facility: Walter Gaman
state: Texas
city: San Antonio
country: United States
facility: Southwest Texas Methodist Hosp
state: Texas
Study officials:
References: