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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002320
First received: November 2, 1999
Last updated: December 8, 2005
Last verified: May 1994
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine
Drug: Zidovudine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 320
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002320

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

Publications:
ClinicalTrials.gov Identifier: NCT00002320     History of Changes
Other Study ID Numbers: 129B, NUCA 3001
Study First Received: November 2, 1999
Last Updated: December 8, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Zidovudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 16, 2014