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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lamivudine
Zidovudine
Zalcitabine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Combat Group
  • San Diego Community Research Group
  • ViRx Inc
  • AIDS Research Consortium of Atlanta
  • Chicago Ctr for Clinical Research
  • Louisiana Cardiovascular Research Ctr
  • Boston City Hosp / FGH-1
  • Nassau County Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Nalle Clinic
  • Duke Univ Med Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Milton S Hershey Med Ctr
  • Central Texas Med Foundation
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Nicholaos Bellos
  • Houston Clinical Research Network
  • Wisconsin Community - Based Research Consortium
  • Ottawa General Hospital
  • Toronto Hosp
  • Montreal Gen Hosp
  • Hosp Regional de Ponce - Area Vieja

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002436
Brief Title
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
325 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Combat Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
San Diego Community Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92104
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Louisiana Cardiovascular Research Ctr
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Boston City Hosp / FGH-1
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Nassau County Med Ctr
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Milton S Hershey Med Ctr
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Nicholaos Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Wisconsin Community - Based Research Consortium
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hosp Regional de Ponce - Area Vieja
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico

12. IPD Sharing Statement

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

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