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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.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 30, 2002
Last updated: March 17, 2011
Last verified: March 2011
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
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:
    • 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00044577

  Show 76 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

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
C Craig, C Stone, T Bonny, K Fu. Similar virology findings in ABC/3TC fixed dose combination (FDC) OAD compared with standard dosing in experienced subjects (CAL30001, ALTO). 7th ICDTHI, Glasgow, UK, 14-18 November 2004. Abstract 98
Clumeck N, Lamarca A, Fu K, Gordon D, Craig C, Zhao H, Paes D, Scott T. Safety and efficacy of a once daily (OAD) Fixed-Dose Combination (FDC) of ABC/3TC [FDC arm] versus ABC twice daily (BID) and 3TC OAD as separate entities [SE arm] in ART-Experienced HIV-1 Infected Patients. 44th ICAAC, Washington, DC, 30 October-2 November 2004. Abstr. H-558

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00044577     History of Changes
Other Study ID Numbers: CAL30001
Study First Received: August 30, 2002
Last Updated: March 17, 2011

Keywords provided by GlaxoSmithKline:
HIV-1 Abacavir Lamivudine Tenofovir

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites processed this record on April 21, 2017