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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00008554 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: GW433908 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
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 |
Estimated Enrollment: | 210 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Ocean View Internal Medicine | |
Long Beach, California, United States, 90803 | |
East Bay Clinical Trial Ctr | |
Concord, California, United States, 94520 | |
United States, Florida | |
Hillsborough County Health Dept | |
Tampa, Florida, United States, 33602 | |
Florida ID Group | |
Orlando, Florida, United States, 32801 | |
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 | |
UMDNJ - New Jersey Med School | |
Newark, New Jersey, United States, 071032757 | |
Saint Michael's Med Ctr | |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
Howard Grossman | |
New York, New York, United States, 10011 | |
Brookdale Univ Hosp and Med Ctr | |
Brooklyn, New York, United States, 112123198 | |
Addiction Research and Treatment Corp | |
Brooklyn, New York, United States, 11201 | |
Gervais Frechette | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
SMO-USA Inc | |
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 | |
Southwest Texas Methodist Hosp | |
San Antonio, Texas, United States, 78229 | |
MacGregor Med Association | |
Houston, Texas, United States, 77054 | |
Walter Gaman | |
Irving, Texas, United States, 75038 | |
Univ of Texas Med Branch | |
Galveston, Texas, United States, 775550835 |
Study ID Numbers: | 316A, APV30001 |
Study First Received: | January 13, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00008554 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors Lamivudine |
Nelfinavir Reverse Transcriptase Inhibitors Anti-HIV Agents abacavir |
Virus Diseases Sexually Transmitted Diseases, Viral Fosamprenavir HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Lamivudine Nelfinavir Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |