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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006617
First received: December 6, 2000
Last updated: August 6, 2008
Last verified: December 2004
  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: Endpoint Classification: Safety Study
Masking: 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)

Resource links provided by NLM:


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

Estimated Enrollment: 25
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
Glaxo Wellcome
Investigators
Principal Investigator: Martin Markowitz
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006617     History of Changes
Other Study ID Numbers: AIEDRP AI-04-008, PROA2003
Study First Received: December 6, 2000
Last Updated: August 6, 2008
Health Authority: United States: Federal Government

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Zidovudine
Abacavir
Reverse Transcriptase Inhibitors
Amprenavir
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
HIV Protease Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014