search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lamivudine
Zidovudine
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 Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

Eligibility Criteria

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

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.

Sites / Locations

  • Combat Group
  • San Diego Community Research Group
  • Pacific Oaks Med Group
  • Harbor - UCLA Med Ctr
  • Infectious Disease Research Institute Inc
  • AIDS Research Consortium of Atlanta
  • Chicago Ctr for Clinical Research
  • Louisiana Cardiovascular Research Ctr
  • CRI of New England
  • Saint Luke's - Roosevelt Hosp Ctr
  • Univ of North Carolina School of Medicine
  • Med College of Ohio
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Mem Hosp of Rhode Island
  • Central Texas Med Foundation
  • Nicholaos Bellos
  • Richmond AIDS Consortium
  • Wisconsin Community - Based Research Consortium
  • Ottawa General Hospital
  • Toronto Hosp
  • Montreal Gen Hosp
  • Advance Community Health Services Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
December 8, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00002320
Brief Title
A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
Official Title
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
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 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
320 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Pacific Oaks Med Group
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
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
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
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
Univ of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Med College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43699
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
Mem Hosp of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Central Texas Med Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Nicholaos Bellos
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
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
Advance Community Health Services Inc
City
Santurce
ZIP/Postal Code
00908
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9030391
Citation
Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996 Dec;10 Suppl 5:S11-9. doi: 10.1097/00002030-199612005-00003.
Results Reference
background
PubMed Identifier
8853730
Citation
Kuritzkes DR, Quinn JB, Benoit SL, Shugarts DL, Griffin A, Bakhtiari M, Poticha D, Eron JJ, Fallon MA, Rubin M. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996 Aug;10(9):975-81. doi: 10.1097/00002030-199610090-00007.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs