Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001758
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 2003

November 3, 1999
March 3, 2008
November 1997
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Complete list of historical versions of study NCT00001758 on ClinicalTrials.gov Archive Site
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Continued Antiretroviral Therapy With Abacavir, Amprenavir and Efavirenz
Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
HIV Infection
  • Drug: Abacavir
  • Drug: Amprenavir
  • Drug: Efavirenz
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
August 2003
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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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001758
980031, 98-I-0031
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institutes of Health Clinical Center (CC)
August 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP