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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00002239

Collaborator

Trimeris (Industry)

Enrollment

Locations

3.4

Patients Per Site

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

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 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pacific Oaks Research	Beverly Hills	California	United States	90211
2	UCLA Care Ctr	Los Angeles	California	United States	90095
3	ViRx Inc	Palm Springs	California	United States	92262
4	Donald Northfelt	Palm Springs	California	United States	92270
5	UCSD	San Diego	California	United States	92103
6	ViRx Inc	San Francisco	California	United States	94109
7	Quest Clinical Research	San Francisco	California	United States	94115
8	Dupont Circle Physicians Group	Washington	District of Columbia	United States	200091104
9	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
10	Gary Richmond MD	Fort Lauderdale	Florida	United States	33316
11	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
12	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
13	Washington Univ School of Medicine	St. Louis	Missouri	United States	63110
14	New York Univ Med Ctr	New York	New York	United States	10016
15	Trimeris Inc	Durham	North Carolina	United States	27707
16	Associates of Med and Mental Health	Tulsa	Oklahoma	United States	74114
17	Pennsylvania Oncology and Hematology Associates	Philadelphia	Pennsylvania	United States	19106
18	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
19	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
20	Central Texas Clinical Research	Austin	Texas	United States	78705