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A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Enfuvirtide (Drug); Ritonavir (Drug); Abacavir sulfate (Drug); Amprenavir (Drug); Efavirenz (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Detailed description: 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pacific Oaks Research, Beverly Hills, California 90211, United States

UCLA Care Ctr, Los Angeles, California 90095, United States

Donald Northfelt, Palm Springs, California 92270, United States

ViRx Inc, Palm Springs, California 92262, United States

UCSD, San Diego, California 92103, United States

Quest Clinical Research, San Francisco, California 94115, United States

ViRx Inc, San Francisco, California 94109, United States

Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Gary Richmond MD, Fort Lauderdale, Florida 33316, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Johns Hopkins Hosp, Baltimore, Maryland 21287, United States

Washington Univ School of Medicine, St. Louis, Missouri 63110, United States

New York Univ Med Ctr, New York, New York 10016, United States

Trimeris Inc, Durham, North Carolina 27707, United States

Associates of Med and Mental Health, Tulsa, Oklahoma 74114, United States

Pennsylvania Oncology and Hematology Associates, Philadelphia, Pennsylvania 19106, United States

Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States

Univ of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States

Central Texas Clinical Research, Austin, Texas 78705, United States

Additional Information

Starting date: May 1999
Last updated: November 14, 2005

Page last updated: August 20, 2015

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