New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2002

Last Updated Date

May 15, 2009

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety [ Time Frame: 48 weeks ]

Original Primary Outcome Measures ^ICMJE

HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety

Change History

Complete list of historical versions of study NCT00044577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Viral load response T-cell count Health Outcomes Resistance

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects

Official Title ^ICMJE

See Detailed Description

Brief Summary

A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.

Detailed Description

A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Drug: abacavir/lamivudine
Drug: abacavir
Drug: lamivudine
Drug: tenofovir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

166

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
Patients must be naive to tenofovir.
HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry.
A CD4 cell count > 50 cells/mm3.
Specified viral genotypes.

Exclusion Criteria:

Pregnant or breast-feeding women.
Has an active diagnosis of AIDS.
Additional qualifying criteria to be determined by the physician.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, France, Germany, Italy, Portugal, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00044577

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

CAL30001

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP