A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy - Full Text View

Purpose

This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.

Condition	Intervention	Phase
HIV Infection	Drug: efavirenz Drug: tenofovir Drug: abacavir/lamivudine	Phase III

MedlinePlus related topics:

AIDS

Drug Information available for:

Abacavir Abacavir sulfate Lamivudine Efavirenz Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III, Randomized, Open-Label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-Dose Combination Tablet as a Once-Daily Regimen in Antiretroviral-Naive HIV-1 Infected Subjects.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Viral load response at 48 weeks [ Time Frame: 48 weeks ]

Secondary Outcome Measures:

Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics [ Time Frame: 48 weeks ]

Estimated Enrollment:	345
Study Start Date:	February 2003

Eligibility

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

Criteria

Inclusion criteria:

Participants must be able to provide informed consent.
Have documented HIV-1 infection.
Have not received more than 14 days of prior treatment with antiretroviral drugs.
Meet laboratory test criteria.
Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.

Exclusion criteria:

Enrolled in other HIV treatment studies.
Pregnant or breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053638

Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ESS30009
First Received:	February 4, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00053638
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HIV-1 Efavirenz Tenofovir

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Tenofovir

Lamivudine

Abacavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Tenofovir disoproxil

Additional relevant MeSH terms:

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:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00053638