A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002239|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 15, 2005
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||68 participants|
|Official Title:||A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults|
|Study Start Date :||May 1999|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
- Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
- Are at least 18 years old.
- Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.
Patients will not be eligible for this study if they:
- Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
- Have an opportunistic (HIV-related) infection.
- Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
- Have had diarrhea lasting at least 15 days within 30 days prior to screening.
- Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
- Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.
- Are allergic to any of the study medications.
- Have a tumor other than certain skin or cervical cancers.
- Are on chemotherapy that cannot be discontinued during the study.
- Are taking an investigational drug within 30 days prior to screening.
- Have ever received an HIV vaccine.
- Are taking certain medications.
- Abuse drugs or alcohol.
- Have hemophilia or another blood clotting disorder.
- Have had an organ transplant.
- Are pregnant or breast-feeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002239
|Other Study ID Numbers:||
|First Posted:||August 31, 2001 Key Record Dates|
|Last Update Posted:||November 15, 2005|
|Last Verified:||November 2005|
Dose-Response Relationship, Drug
Drug Therapy, Combination
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors