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

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 III

MedlinePlus related topics:

AIDS

Drug Information available for:

Zidovudine Lamivudine Zalcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

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

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
	ViRx Inc
	San Francisco, California, United States, 94103
	Combat Group
	Los Angeles, California, United States, 90028
	San Diego Community Research Group
	San Diego, California, United States, 92104

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
	Saint Luke's - Roosevelt Hosp Ctr
	New York, New York, United States, 10019
	Nassau County Med Ctr
	East Meadow, New York, United States, 11554

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
	Univ of Texas Southwestern Med Ctr of Dallas
	Dallas, Texas, United States, 75235
	Houston Clinical Research Network
	Houston, Texas, United States, 77006
	Nicholaos Bellos
	Dallas, Texas, United States, 75246
	Central Texas Med Foundation
	Austin, Texas, United States, 78751

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

Study ID Numbers:	129C, NUCA 3002
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002436
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Zalcitabine

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

AIDS-Related Complex

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002436