Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Glaxo Wellcome |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00005106 |
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects |
Estimated Enrollment: | 230 |
Study Start Date: | September 1999 |
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
Ages Eligible for Study: | 18 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:
Study ID Numbers: | 264P, ESS40002 |
Study First Received: | April 6, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005106 |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors Lamivudine Nelfinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Adipose Tissue Lipodystrophy abacavir |
Sexually Transmitted Diseases, Viral Stavudine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes Virus Diseases |
HIV Infections Lipodystrophy Sexually Transmitted Diseases Abacavir Nelfinavir Retroviridae Infections |
Antimetabolites 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 |