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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Lamivudine Indinavir Indinavir Sulfate Nelfinavir Nelfinavir Mesylate Stavudine

U.S. FDA Resources

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
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, United States, 94304
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
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
Steinhart Medical Associates
Miami, Florida, United States, 33133
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
Southwest Infectious Disease Association / PA
Dallas, Texas, United States, 75225
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002442 History of Changes
Other Study ID Numbers:	225C, COLA 4005
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:

Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Lamivudine

Indinavir
Dosage Forms
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents

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
HIV Protease Inhibitors
Indinavir
Nelfinavir

Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012