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| Sponsored by: |
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 |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Abacavir Abacavir sulfate Lamivudine Nelfinavir Nelfinavir Mesylate Fosamprenavir Fosamprenavir calcium Fosamprenavir sodium |
| 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 | |||||
| Glaxo Wellcome |
More Information
| Study ID Numbers: | 316A, APV30001 |
| First Received: | January 13, 2001 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00008554 |
| Health Authority: | United States: Food and Drug Administration |
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