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A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Abacavir sulfate
Amprenavir
Nelfinavir mesylate
Lamivudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Nelfinavir, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria You may be eligible for this trial if you: Are HIV-positive. Are 13 years of age or older. Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks. In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs. Have the written consent of a parent or legal guardian if you are under age 18. Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant). Are willing to complete the 48-week study. Exclusion Criteria You will not be eligible for this trial if you: Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride. Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma. Have had certain types of hepatitis in the past 6 months. Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days. Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth. Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.

Sites / Locations

  • Saint Francis Mem Hosp
  • Georgetown Univ Med Ctr
  • IDC Research Initiative
  • Natl Institute of Allergy and Infectious Diseases
  • Kansas City AIDS Research Consortium
  • Bentley-Salick Med Practice
  • Associates in Med and Mental Health
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002423
Brief Title
A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
Official Title
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.
Detailed Description
Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Indinavir, Nelfinavir, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this trial if you: Are HIV-positive. Are 13 years of age or older. Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks. In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs. Have the written consent of a parent or legal guardian if you are under age 18. Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant). Are willing to complete the 48-week study. Exclusion Criteria You will not be eligible for this trial if you: Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride. Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma. Have had certain types of hepatitis in the past 6 months. Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days. Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth. Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
Facility Information:
Facility Name
Saint Francis Mem Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Natl Institute of Allergy and Infectious Diseases
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Bentley-Salick Med Practice
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
972109951
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

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