A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
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| ClinicalTrials.gov Identifier: NCT00002239 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 15, 2005
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Sponsor:
Hoffmann-La Roche
Collaborator:
Trimeris
Information provided by:
Hoffmann-La Roche
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Brief Summary:
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz | Phase 2 |
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 68 participants |
| Primary Purpose: | Treatment |
| 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Information from the National Library of Medicine
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
Locations
Show 20 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Trimeris
| ClinicalTrials.gov Identifier: | NCT00002239 |
| Other Study ID Numbers: |
T20-206 295B |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 15, 2005 |
| Last Verified: | November 2005 |
Keywords provided by Hoffmann-La Roche:
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HIV-1 Dose-Response Relationship, Drug Drug Therapy, Combination VX 478 |
Anti-HIV Agents pentafuside abacavir efavirenz |
Additional relevant MeSH terms:
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Amprenavir Abacavir |
Enfuvirtide Efavirenz HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |