A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

December 8, 2005 updated by: Glaxo Wellcome

A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3

To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients.

PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment for 32 weeks, with possible extension to 52 weeks.

PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.

Study Type

Interventional

Enrollment

320

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
      • Ottawa, Ontario, Canada
        • Ottawa General Hospital
      • Toronto, Ontario, Canada
        • Toronto Hosp
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal Gen Hosp
  • Puerto Rico
      • Santurce, Puerto Rico, 00908
        • Advance Community Health Services Inc
  • United States
    • California
      • Los Angeles, California, United States, 90028
        • Combat Group
      • San Diego, California, United States, 92104
        • San Diego Community Research Group
      • Sherman Oaks, California, United States, 91403
        • Pacific Oaks Med Group
      • Torrance, California, United States, 90509
        • Harbor - UCLA Med Ctr
    • Florida
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Ctr for Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Louisiana Cardiovascular Research Ctr
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • CRI of New England
    • New York
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina School of Medicine
    • Ohio
      • Toledo, Ohio, United States, 43699
        • Med College of Ohio
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Mem Hosp of Rhode Island
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75246
        • Nicholaos Bellos
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Wisconsin Community - Based Research Consortium

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV positivity.
  • CD4 count 200-500 cells/mm3.
  • AZT naive status (<= 4 weeks of prior AZT).

Exclusion Criteria

Patients with the following prior condition are excluded:

History of intolerance to AZT.

Prior Medication:

Excluded:

  • More than 4 weeks of prior AZT.
  • Any prior antiretroviral treatment other than AZT.

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Glaxo Wellcome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 12, 2005

Last Update Submitted That Met QC Criteria

December 8, 2005

Last Verified

May 1, 1994

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 129B
  • NUCA 3001

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.

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