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Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Amprenavir
Lamivudine
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Zidovudine, Lymphoid Tissue, Gastrointestinal System, HIV Protease Inhibitors, Lamivudine, Lymphocyte Subsets, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Cerebrospinal Fluid, abacavir

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 at least 18 years old. Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection. Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only). Are able to follow study requirements. Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study. Exclusion Criteria Patients will not be eligible for this study if they: Have had prior anti-HIV treatment (for recently infected patients only). Have a history of blood-clotting problems. Have ever received treatment with protease inhibitors or 3TC. Are at high risk for developing an infection in the heart. Are critically ill. Are mentally disabled, a prisoner, or confined in an institution. Are breast-feeding or pregnant. Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth. Need regular blood transfusions. Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment. Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study). Are taking certain medications that may interfere with the study.

Sites / Locations

  • Aaron Diamond AIDS Res Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
May 14, 2015
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00006617
Brief Title
Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
Official Title
An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues. HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.
Detailed Description
With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3 weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages, with a minimal contribution from lymphocytes. This study addresses whether there is a third reservoir such as the central nervous system. Additionally, the study aims to provide a better understanding of the type and length of ART required to suppress HIV-1 replication in multiple reservoirs. Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine samples are collected and patients are monitored for clinical or laboratory abnormalities. Laboratory tests to assess side effects and virologic and immunologic parameters, including viral quantification of CSF on all chronically infected patients and selected consenting acutely infected patients, are determined. In a pharmacoeconomic component of this study, patients have interviews and complete questionnaires at 5 clinic visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, Lymphoid Tissue, Gastrointestinal System, HIV Protease Inhibitors, Lamivudine, Lymphocyte Subsets, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Cerebrospinal Fluid, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

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 at least 18 years old. Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection. Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only). Are able to follow study requirements. Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study. Exclusion Criteria Patients will not be eligible for this study if they: Have had prior anti-HIV treatment (for recently infected patients only). Have a history of blood-clotting problems. Have ever received treatment with protease inhibitors or 3TC. Are at high risk for developing an infection in the heart. Are critically ill. Are mentally disabled, a prisoner, or confined in an institution. Are breast-feeding or pregnant. Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth. Need regular blood transfusions. Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment. Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study). Are taking certain medications that may interfere with the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Markowitz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aaron Diamond AIDS Res Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients

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