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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Nelfinavir mesylate
Lamivudine
GW433908
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Bay Clinical Trial Ctr
  • Ocean View Internal Medicine
  • Florida ID Group
  • Hillsborough County Health Dept
  • Clinical Pharmacology Services
  • Veterans Affairs Med Ctr of North Chicago
  • Univ of Kansas Med Ctr
  • Saint Michael's Med Ctr
  • UMDNJ - New Jersey Med School
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • Addiction Research and Treatment Corp
  • Brookdale Univ Hosp and Med Ctr
  • Gervais Frechette
  • Howard Grossman
  • Mount Sinai School of Medicine
  • Univ of Rochester Med Ctr
  • SMO-USA Inc
  • Advanced Clinical Trials Inc
  • Thomas Jefferson Univ
  • Univ of Texas Med Branch
  • MacGregor Med Association
  • Walter Gaman
  • Southwest Texas Methodist Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 13, 2001
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00008554
Brief Title
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

2. Study Status

Record Verification Date
July 2001
Overall Recruitment Status
Unknown status
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
GW433908

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
East Bay Clinical Trial Ctr
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Ocean View Internal Medicine
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
Florida ID Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Hillsborough County Health Dept
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Clinical Pharmacology Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Veterans Affairs Med Ctr of North Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Univ of Kansas Med Ctr
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
661607415
Country
United States
Facility Name
Saint Michael's Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
UMDNJ - New Jersey Med School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032757
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Brookdale Univ Hosp and Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112123198
Country
United States
Facility Name
Gervais Frechette
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SMO-USA Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Advanced Clinical Trials Inc
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Thomas Jefferson Univ
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
MacGregor Med Association
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Walter Gaman
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Southwest Texas Methodist Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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