Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
Glaxo Wellcome

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00006617

First received: December 6, 2000
Last updated: May 14, 2015
Last Verified: December 2004
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections

Drug : Abacavir sulfate
Drug : Amprenavir
Drug : Lamivudine
Drug : Zidovudine

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 25
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006617

Locations

United States, New York
Aaron Diamond AIDS Res Ctr
New York, New York, United States, 10016

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Glaxo Wellcome

Investigators

Principal Investigator: Martin Markowitz
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00006617   History of Changes  
Other Study ID Numbers: AI-04-008  
  PROA2003  
  AIEDRP AI-04-008  
Study First Received: December 6, 2000  
Last Updated: May 14, 2015  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:
HIV Infections
Lamivudine
Zidovudine
Abacavir
Amprenavir

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.