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| Tracking Information | |||||
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| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002245 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients | ||||
| Official Title ICMJE | Effect of Amprenavir on Carbohydrate and Lipid Metabolism in Patients With HIV Infection | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy. |
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| Detailed Description | This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Safety Study | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients may be eligible for this study if they:
Exclusion Criteria Patients will not be eligible for this study if they:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002245 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 264L, COL30309 | ||||
| Study Sponsor ICMJE | Glaxo Wellcome | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | NIH AIDS Clinical Trials Information Service | ||||
| Verification Date | August 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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