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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00008554 |
Purpose
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.
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | 316A, APV30001 |
| Study First Received: | January 13, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00008554 History of Changes |
| 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 |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Abacavir Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Fosamprenavir HIV Infections Sexually Transmitted Diseases Lentivirus Infections |