The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

June 23, 2005 updated by: Glaxo Wellcome

A Randomized Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected, AZT-Experienced (>= 24 Weeks) Patients With CD4 Counts of 100-300 Cells/mm3

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.

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 three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues 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

325

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
      • Ponce, Puerto Rico, 00731
        • Hosp Regional de Ponce - Area Vieja
  • United States
    • California
      • Los Angeles, California, United States, 90028
        • Combat Group
      • San Diego, California, United States, 92104
        • San Diego Community Research Group
      • San Francisco, California, United States, 94103
        • ViRx 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
      • Boston, Massachusetts, United States, 02118
        • Boston City Hosp / FGH-1
    • New York
      • East Meadow, New York, United States, 11554
        • Nassau County Med Ctr
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S Hershey Med Ctr
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Dallas, Texas, United States, 75246
        • Nicholaos Bellos
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV positivity.
  • CD4 count 100-300 cells/mm3.
  • Prior AZT therapy for 24 or more weeks and currently on AZT.

Exclusion Criteria

Patients with the following prior conditions are excluded:

  • History of intolerance to AZT.
  • History of grade 2 or worse peripheral neuropathy.

Prior Medication:

Excluded:

  • Any prior antiretroviral therapy other than AZT.

Required:

  • Concomitant AZT therapy.

Required:

  • At least 24 weeks of prior 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

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

May 1, 1994

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 129C
  • NUCA 3002

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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