Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
Verified July 2001
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: January 13, 2001
Last updated: June 23, 2005
Last Verified: July 2001
History of Changes
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.
Drug : Abacavir sulfate
Drug : Nelfinavir mesylate
Drug : Lamivudine
Drug : GW433908
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
|Study Start Date:||November 2000|
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
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008554
Locations Show More
|United States, California|
|East Bay Clinical Trial Ctr|
|Concord, California, United States, 94520|
|Ocean View Internal Medicine|
|Long Beach, California, United States, 90803|
|United States, Florida|
|Florida ID Group|
|Orlando, Florida, United States, 32801|
|Hillsborough County Health Dept|
|Tampa, Florida, United States, 33602|
|Clinical Pharmacology Services|
|Tampa, Florida, United States, 33617|
|United States, Illinois|
|Veterans Affairs Med Ctr of North Chicago|
|Chicago, Illinois, United States, 60064|
|United States, Kansas|
|Univ of Kansas Med Ctr|
|Kansas City, Kansas, United States, 661607415|
|United States, New Jersey|
|Saint Michael's Med Ctr|
|Newark, New Jersey, United States, 07102|
|UMDNJ - New Jersey Med School|
|Newark, New Jersey, United States, 071032757|
|United States, New York|
|Bronx Municipal Hosp Ctr/Jacobi Med Ctr|
|Bronx, New York, United States, 10461|
|Addiction Research and Treatment Corp|
|Brooklyn, New York, United States, 11201|
|Brookdale Univ Hosp and Med Ctr|
|Brooklyn, New York, United States, 112123198|
|New York, New York, United States, 10011|
|New York, New York, United States, 10011|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Univ of Rochester Med Ctr|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28211|
|United States, Oregon|
|Advanced Clinical Trials Inc|
|Eugene, Oregon, United States, 97401|
|United States, Pennsylvania|
|Thomas Jefferson Univ|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Univ of Texas Med Branch|
|Galveston, Texas, United States, 775550835|
|MacGregor Med Association|
|Houston, Texas, United States, 77054|
|Irving, Texas, United States, 75038|
|Southwest Texas Methodist Hosp|
|San Antonio, Texas, United States, 78229|
Sponsors and CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov Identifier:||NCT00008554 History of Changes|
|Other Study ID Numbers:||316A|
|Study First Received:||January 13, 2001|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.