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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | November 1997 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001758 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz |
| Official Title ICMJE | Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz |
| Brief Summary | This study will continue to treat and collect safety and efficacy data on patients who participated in Glaxo-Wellcome's multi-center study on combination therapy with abacavir, amprenavir and efavirenz (A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy with 1592U89, 141W94 and DMP 266 (Sustiva) in HIV-1 Infected Subjects with Detectable [greater than 400 Copies/mL] HIV-1 Plasma RNA Despite Treatment with a Protease Inhibitor-Containing Regimen). HIV-infected patients 18 years of age and older who participated in the above study at the NIH site may be eligible for the current study. Participants will be followed every 3 months with a general health evaluation and laboratory tests. This is a NIH study, and information will not be provided to Glaxo Wellcome |
| Detailed Description | In this open-label, single-arm study, HIV-1 infected patients who had, at study entry, a viral burden of at least 500 copies/mL despite 20 weeks of treatment with a protease inhibitor receive combination therapy with three antiretroviral agents that were investigational at the start of study but have since been approved: abacavir, amprenavir, and efavirenz. At the end of 16 weeks, the addition of other antiretroviral agents to the study regimen was permitted. This was originally a multi-center study, but it has been closed at all other sites. It remains open at the NIH to continue to provide therapy to subjects who have received benefit as determined by a decline in viral load from baseline. Safety and viral load data continue to be collected. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety/Efficacy Study |
| Condition ICMJE | HIV Infection |
| 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 | 25 |
| Completion Date | August 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | INCLUSION/EXCLUSION CRITERIA: Subjects who were previously enrolled in this protocol when it was a multi-center study and who signed the new informed consent were enrolled. There has been and will be no other new enrollment. Thus, subjects who were not previously enrolled are excluded. Subjects are adults infected with HIV-1 who had, prior to study enrollment, a plasma viral load of at least 500 copies/mL despite at least 20 weeks of treatment with a protease inhibitor and without change in protease inhibitor therapy in the 12 weeks prior to enrollment. |
| Gender | Both |
| Ages | |
| 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 | NCT00001758 |
| Responsible Party | |
| Study ID Numbers ICMJE | 980031, 98-I-0031 |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2003 |
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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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