3TC (Lamivudine; GR109714X) Open-Label Program - Full Text View

Purpose

To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.

Condition	Intervention
HIV Infections	Drug: Lamivudine Drug: Zidovudine

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Zidovudine Lamivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety Study

Official Title:	3TC (Lamivudine; GR109714X) Open-Label Program

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

Detailed Description:

Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patient's physician or until termination of the program. Patients < 12 years receive a lower dose of 3TC. Patients are followed monthly. For selected sites only, serum samples are collected every 3 months from patients identified as HBsAg positive.

PER 02/28/95 AMENDMENT: Patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine.

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients must:

Have progressive, symptomatic HIV disease.
Have a mean CD4 count <= 99 cells/mm3 for adults and <= 300 cells/mm3 for children (original design was CD4 count <= 300 cells/mm3 for both adults and children).
Be unable to participate in a controlled trial.
Be refractory to or unable to tolerate other therapies.
Be able to attend clinic on a monthly schedule.
Have consent of parent or guardian if under the age of consent.

NOTE:

If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case.

Practice of unsafe sex.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002108

Locations


United States, New Jersey
	Kern - McNeill International
	Morristown, New Jersey, United States, 07960

Sponsors and Collaborators

Glaxo Wellcome

More Information

Publications:

Pluda J, Cooley T, Montaner J, McCaffrey R, Wainberg M, Yarchoan R. Phase I/II study of 3TC (GR109714X) in adults with ARC or AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-2)

Study ID Numbers:	129D, NUCA 3004
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002108
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

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 September 16, 2008

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002108