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
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus I Infection
HIV Infection
Drug: abacavir/lamivudine
Drug: abacavir
Drug: lamivudine
Drug: tenofovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Viral load response T-cell count Health Outcomes Resistance

Estimated Enrollment: 166
Study Start Date: July 2002
Intervention Details:
    Drug: abacavir/lamivudine Drug: abacavir Drug: lamivudine Drug: tenofovir
    Other Names:
    • tenofovir
    • lamivudine
    • abacavir/lamivudine
    • abacavir
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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044577

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90046
GSK Investigational Site
Oakland, California, United States, 94602
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33145
GSK Investigational Site
Fort Myers, Florida, United States, 33901
GSK Investigational Site
Jacksonville, Florida, United States, 32206
GSK Investigational Site
Miami Beach, Florida, United States, 33140
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Plantation, Florida, United States, 33317
GSK Investigational Site
Tampa, Florida, United States, 33602
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30308/30309
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63108
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10468
GSK Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19131
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Dallas, Texas, United States, 75204
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98104
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liege, Belgium, 4000
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 6N5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2C4
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H2L 5B1
GSK Investigational Site
Montreal, Quebec, Canada, H2L 4P9
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G2
France
GSK Investigational Site
Garches, France, 92380
GSK Investigational Site
Le Kremlin Bicêtre Cedex, France, 94275
GSK Investigational Site
Levallois-Perret, France, 92300
GSK Investigational Site
Lyon Cedex 03, France, 69437
GSK Investigational Site
Paris Cedex 13, France, 75651
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Hamburg, Germany, 20099
Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Modena, Emilia-Romagna, Italy, 41100
GSK Investigational Site
Brescia, Lombardia, Italy, 25125
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Verona, Veneto, Italy, 37135
Portugal
GSK Investigational Site
Braga, Portugal, 4700-308
GSK Investigational Site
Cascais, Portugal, 2750
GSK Investigational Site
Coimbra, Portugal, 3000-075
GSK Investigational Site
Faro, Portugal, 8000-386
GSK Investigational Site
Lisboa, Portugal
GSK Investigational Site
Lisboa, Portugal, 1769-001
Spain
GSK Investigational Site
Barcelona, Spain, 8400
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Madrid, Spain, 28047
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Marbella, Spain, 29600
United Kingdom
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
GSK Investigational Site
Thornton Heath, Surrey, United Kingdom, CR7 7YE
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
London, United Kingdom, W2 1NY
GSK Investigational Site
London, United Kingdom, SW10 9TH
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications:
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

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00044577     History of Changes
Other Study ID Numbers: CAL30001
Study First Received: August 30, 2002
Last Updated: March 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 Abacavir Lamivudine Tenofovir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Lamivudine
Tenofovir
Tenofovir disoproxil
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 26, 2014