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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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study 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 |
| Estimated Enrollment: | 68 |
| Study Start Date: | May 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Pacific Oaks Research | |
| Beverly Hills, California, United States, 90211 | |
| UCLA Care Ctr | |
| Los Angeles, California, United States, 90095 | |
| ViRx Inc | |
| Palm Springs, California, United States, 92262 | |
| Donald Northfelt | |
| Palm Springs, California, United States, 92270 | |
| UCSD | |
| San Diego, California, United States, 92103 | |
| Quest Clinical Research | |
| San Francisco, California, United States, 94115 | |
| ViRx Inc | |
| San Francisco, California, United States, 94109 | |
| United States, District of Columbia | |
| Dupont Circle Physicians Group | |
| Washington, District of Columbia, United States, 200091104 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| Gary Richmond MD | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Trimeris Inc | |
| Durham, North Carolina, United States, 27707 | |
| United States, Oklahoma | |
| Associates of Med and Mental Health | |
| Tulsa, Oklahoma, United States, 74114 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Pennsylvania Oncology and Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Texas | |
| Central Texas Clinical Research | |
| Austin, Texas, United States, 78705 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002239 History of Changes |
| Other Study ID Numbers: | T20-206, 295B |
| Study First Received: | November 2, 1999 |
| Last Updated: | November 14, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hoffmann-La Roche:
|
HIV-1 Dose-Response Relationship, Drug Drug Therapy, Combination VX 478 |
Anti-HIV Agents pentafuside abacavir efavirenz |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir Amprenavir Enfuvirtide Efavirenz |
Abacavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses HIV Fusion Inhibitors Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents |
ClinicalTrials.gov processed this record on May 23, 2013