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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002436
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1994
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Estimated Enrollment: 325
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002436

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002436     History of Changes
Other Study ID Numbers: 129C, NUCA 3002
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zalcitabine
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
Zalcitabine
Zidovudine
 Lamivudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 13, 2013