The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

June 23, 2005 updated by: Glaxo Wellcome

A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC/ZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts >= 100 Cells/mm3

To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone. If a patient has two consecutive HIV-1 RNA measurements of >= 400 copies/ml (performed at least one week apart) he or she has the option to switch to open-label therapy with 1592U89/3TC/ZDV, to receive the remaining randomized treatment, or to discontinue study medication. If this criterion is not met, patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy. Once patients enter the open-label phase, investigators may add or substitute non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, or protease inhibitors for 3TC and/or ZDV according to their standard practice once patients enter the open-label phase.

Study Type

Interventional

Enrollment

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
  • Puerto Rico
      • Santurce, Puerto Rico, 00907
        • San Juan AIDS Program
  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Los Angeles, California, United States, 90036
        • Kraus Med Partners
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami Dept of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Med College / Rush Presbyterian - St Luke's Med Cen
    • Massachusetts
      • Boston, Massachusetts, United States, 021182393
        • Boston Med Ctr / Evans - 556
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Med Ctr / Dept of Infectious Diseases
    • New York
      • New York, New York, United States, 10011
        • St Vincent's Hosp and Med Ctr / AIDS Ctr
      • New York, New York, United States, 10027
        • Harlem Hosp
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr / Dept of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati / Holmes Hosp
    • Texas
      • Dallas, Texas, United States, 75225
        • Dr Nicholaos Bellos
      • Houston, Texas, United States, 770303498
        • Baylor College of Medicine / Dept of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Local treatment for Kaposi's sarcoma.
  • Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.

Patients must have:

  • HIV-1 infection as documented by a licensed HIV-1 antibody ELISA and confirmed by either Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
  • One screening CD4 lymphocyte cell count >= 100 cells/mm3 within 14 days prior to study drug administration.
  • No active or ongoing AIDS-defining opportunistic infection or disease.
  • Signed, informed consent from parent or legal guardian for patients under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

  • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
  • Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that, in the opinion of the investigator, would compromise the safety of the patient.

Concurrent Medication:

Excluded:

  • Foscarnet therapy.
  • Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents, or interferons.
  • Cytotoxic chemotherapeutic agents and antioxidants.

Concurrent Treatment:

Excluded:

Radiation therapy.

Patients with the following prior conditions are excluded:

History of clinically relevant pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

  • Prior antiretroviral therapy.
  • Vaccination within the past 3 months given as part of an investigational HIV vaccine trial.
  • Chemotherapeutic agents within 30 days of study drug administration.
  • Immunomodulating agents such as systemic corticosteroids, interleukins or interferons, within 30 days of study drug administration.

Prior Treatment:

Excluded:

Radiation therapy within 30 days of study period. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Lamivudine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe