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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00044577
First received: August 30, 2002
Last updated: March 17, 2011
Last verified: March 2011

August 30, 2002
March 17, 2011
July 2002
Not Provided
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety [ Time Frame: 48 weeks ]
Not Provided
Complete list of historical versions of study NCT00044577 on ClinicalTrials.gov Archive Site
Viral load response T-cell count Health Outcomes Resistance
Not Provided
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New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
See Detailed Description

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Human Immunodeficiency Virus I Infection
  • HIV Infection
  • Drug: abacavir/lamivudine
  • Drug: abacavir
  • Drug: lamivudine
  • Drug: tenofovir
    Other Names:
    • tenofovir
    • lamivudine
    • abacavir/lamivudine
    • abacavir
Not Provided
EFFICACY AND SAFETY OF A ONCE DAILY FIXED-DOSE COMBINATION OF ABACAVIR/LAMIVUDINE (ABC/3TC) [FDC ] VERSUS ABC TWICE DAILY AND 3TC ONCE DAILY AS SEPARATE ENTITIES [SE] IN ART-EXPERIENCED HIV-1 INFECTED SUBJECTS (CAL30001): 48 WEEK DATA. Clumeck, N., LaMarca, A., Fu, K., Gordon, D., Craig, C., Zhao, H. , Paes, D., and Scott, T. (WePe6.3C13), 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, Rio de Janeiro; Brazil, 7/24/2005

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany,   Italy,   Portugal,   Spain,   United Kingdom
 
NCT00044577
CAL30001
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
March 2011

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