A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs - Full Text View

A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs

This study has been completed.

Sponsored by:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002442

Purpose

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.

Condition	Intervention	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Stavudine	Phase II

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Zidovudine Lamivudine Indinavir Indinavir Sulfate Stavudine Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

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

Official Title:	A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection

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

Study Start Date:

June 1999

Detailed Description:

Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Are at least 18 years old.
Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
Have a CD4 cell count of at least 50 cells/mm3.
Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
Agree to abstain from sex or use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have a history of an AIDS-defining illness or certain other medical conditions.
Are allergic to any of the study drugs.
Are unable to take medication by mouth for any reason.
Have received certain medications.
Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
Are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002442

Locations


United States, California
	Palo Alto Veterans Affairs Health Care System
	Palo Alto, California, United States, 94304
	AIDS Healthcare Foundation
	Los Angeles, California, United States, 90027

United States, District of Columbia
	Dupont Circle Physicians Group
	Washington, District of Columbia, United States, 200091104

United States, Florida
	IDC Research Initiative
	Altamonte Springs, Florida, United States, 32701
	Steinhart Medical Associates
	Miami, Florida, United States, 33133
	North Broward Hosp District
	Fort Lauderdale, Florida, United States, 33316

United States, Illinois
	Northwestern Univ Med School
	Chicago, Illinois, United States, 60611

United States, New York
	St Lukes - Roosevelt Hosp Ctr
	New York, New York, United States, 10019
	Saint Vincents Hosp
	New York, New York, United States, 10011

United States, Pennsylvania
	MCP Hahnemann Univ Hosp
	Philadelphia, Pennsylvania, United States, 19102

United States, Texas
	Univ TX Galveston Med Branch
	Galveston, Texas, United States, 77550
	Southwest Infectious Disease Association / PA
	Dallas, Texas, United States, 75225

Sponsors and Collaborators

Glaxo Wellcome

More Information

Study ID Numbers:	225C, COLA 4005
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002442
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Zidovudine

Drug Administration Schedule

Stavudine

HIV Protease Inhibitors

Lamivudine

Indinavir

Dosage Forms

Nelfinavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Indinavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Nelfinavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Communicable Diseases

HIV Protease Inhibitors

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008