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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enfuvirtide
Ritonavir
Abacavir sulfate
Amprenavir
Efavirenz
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, abacavir, efavirenz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pacific Oaks Research
  • UCLA Care Ctr
  • ViRx Inc
  • Donald Northfelt
  • UCSD
  • ViRx Inc
  • Quest Clinical Research
  • Dupont Circle Physicians Group
  • IDC Research Initiative
  • Gary Richmond MD
  • AIDS Research Consortium of Atlanta
  • Johns Hopkins Hosp
  • Washington Univ School of Medicine
  • New York Univ Med Ctr
  • Trimeris Inc
  • Associates of Med and Mental Health
  • Pennsylvania Oncology and Hematology Associates
  • Philadelphia FIGHT
  • Univ of Pittsburgh
  • Central Texas Clinical Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
November 14, 2005
Sponsor
Hoffmann-La Roche
Collaborators
Trimeris
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1. Study Identification

Unique Protocol Identification Number
NCT00002239
Brief Title
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
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 Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche
Collaborators
Trimeris

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
68 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Enfuvirtide
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Efavirenz

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCLA Care Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
ViRx Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Donald Northfelt
City
Palm Springs
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
UCSD
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Trimeris Inc
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Associates of Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Pennsylvania Oncology and Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

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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

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