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

NCT00044577 | Completed Phase 3

• 1 other identifier: CAL30001
• Study Type: interventional
• Target: 166
• Locations: 9 countries
• Sites: 76

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.

Conditions

Infection, Human Immunodeficiency Virus I; HIV Infection

Keywords

HIV-1 Abacavir Lamivudine Tenofovir

Outcome Measures

Primary Outcomes (1)

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

  48 weeks

Secondary Outcomes (1)

• Viral load response T-cell count Health Outcomes Resistance

Interventions

abacavir/lamivudine DRUG

abacavir DRUG

lamivudine DRUG

tenofovir DRUG

Also known as: lamivudine, abacavir/lamivudine, abacavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (76)

GSK Investigational Site

Los Angeles, California, 90046, United States

Location

GSK Investigational Site

Oakland, California, 94602, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33145, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33901, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32206, United States

Location

GSK Investigational Site

Miami Beach, Florida, 33140, United States

Location

GSK Investigational Site

Orlando, Florida, 32804, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Plantation, Florida, 33317, United States

Location

GSK Investigational Site

Tampa, Florida, 33602, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308/30309, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30339, United States

Location

GSK Investigational Site

Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

St Louis, Missouri, 63108, United States

Location

GSK Investigational Site

Stony Brook, New York, 11794, United States

Location

GSK Investigational Site

The Bronx, New York, 10468, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28209, United States

Location

GSK Investigational Site

Akron, Ohio, 44304, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19102, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19131, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29206-4713, United States

Location

GSK Investigational Site

Dallas, Texas, 75204, United States

Location

GSK Investigational Site

Dallas, Texas, 75208, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Seattle, Washington, 98104, United States

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

GSK Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1N 6N5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5B 1W8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2C4, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 4P9, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2L 5B1, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

GSK Investigational Site

Garches, 92380, France

Location

GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

Location

GSK Investigational Site

Levallois-Perret, 92300, France

Location

GSK Investigational Site

Lyon, 69437, France

Location

GSK Investigational Site

Paris, 75651, France

Location

GSK Investigational Site

Munich, Bavaria, 80335, Germany

Location

GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Hamburg, 20099, Germany

Location

GSK Investigational Site

Ferrara, Emilia-Romagna, 44100, Italy

Location

GSK Investigational Site

Modena, Emilia-Romagna, 41100, Italy

Location

GSK Investigational Site

Brescia, Lombardy, 25125, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20157, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10149, Italy

Location

GSK Investigational Site

Verona, Veneto, 37135, Italy

Location

GSK Investigational Site

Braga, 4700-308, Portugal

Location

GSK Investigational Site

Cascais, 2750, Portugal

Location

GSK Investigational Site

Coimbra, 3000-075, Portugal

Location

GSK Investigational Site

Faro, 8000-386, Portugal

Location

GSK Investigational Site

Lisbon, 1769-001, Portugal

Location

GSK Investigational Site

Lisbon, Portugal

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 8400, Spain

Location

GSK Investigational Site

Elche (Alicante), 03202, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Marbella, 29600, Spain

Location

GSK Investigational Site

Manchester, Lancashire, M8 5RB, United Kingdom

Location

GSK Investigational Site

Thornton Heath, Surrey, CR7 7YE, United Kingdom

Location

GSK Investigational Site

London, NW3 2QG, United Kingdom

Location

GSK Investigational Site

London, SE5 9RS, United Kingdom

Location

GSK Investigational Site

London, SW10 9TH, United Kingdom

Location

GSK Investigational Site

London, SW17 0QT, United Kingdom

Location

GSK Investigational Site

London, W2 1NY, United Kingdom

Location

Related Publications (3)

• 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

  RESULT

• 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

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Infections; HIV Infections

Interventions

abacavir, lamivudine drug combination; abacavir; Lamivudine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2002
• First Posted: September 4, 2002
• Study Start: July 16, 2002
• Primary Completion: May 25, 2004
• Study Completion: May 25, 2004
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CA (8); IT (6); FR (5); US (30); PT (6); ES (6); DE (5); GB (7); BE (3)