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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001758 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: Abacavir Drug: Amprenavir Drug: Efavirenz |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety/Efficacy Study |
| Official Title: | Continued Salvage Anti-Retroviral Therapy With Abacavir, Amprenavir, and Efavirenz |
| Estimated Enrollment: | 25 |
| Study Start Date: | November 1997 |
| Estimated Study Completion Date: | August 2003 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 980031, 98-I-0031 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001758 |
| Health Authority: | United States: Federal Government |
|
Antiretroviral HIV-1 1592U89 141W94 DMP 266 |
|
Virus Diseases Efavirenz Amprenavir Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Abacavir Retroviridae Infections Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Reverse Transcriptase Inhibitors Antibiotics, Antitubercular Protease Inhibitors Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Antitubercular Agents Nucleic Acid Synthesis Inhibitors |
