Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00008554
• Other study ID #: 316A
• Secondary ID: APV30001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 13, 2001
• Last updated: June 23, 2005
• Start date: November 2000

Study information

• Verified date: July 2001
• 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

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

• Nelfinavir mesylate

• Lamivudine

• GW433908

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,