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A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00046176
Recruitment Status : Completed
First Posted : September 23, 2002
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus I HIV Infection Drug: abacavir/lamivudine Drug: abacavir Drug: lamivudine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, 48-Week, Open-Label, Randomized, Multicenter Study of the Safety and Efficacy of the Abacavir/Lamivudine Fixed-Dose Combination Tablet Administered QD Versus Abacavir + Lamivudine Administered BID in Combination With a PI or NNRTI in Antiretroviral Experienced Patients.
Actual Study Start Date : August 26, 2002
Actual Primary Completion Date : May 17, 2004
Actual Study Completion Date : May 17, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Drug: abacavir/lamivudine
  • Drug: abacavir
  • Drug: lamivudine
    Other Names:
    • abacavir
    • abacavir/lamivudine

Primary Outcome Measures :
  1. Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at least 24 weeks.
  • NOTE: Subjects who have required a change in initial protease inhibitor (PI) or NNRTI therapy due to intolerance (not treatment failure) are eligible. Subject must be on a stable regimen of the second PI or NNRTI therapy for at least 6 months before enrollment in this study.
  • Plasma HIV-1 RNA less than 400 copies/mL for at least 3 months immediately preceding the screening visit, and at screening.
  • CD4+ cell count of at least 50 cells/mm3 at screening.
  • Written informed consent to participate in the study before participation.
  • Male or female (Females of child-bearing potential must have a negative serum pregnancy test at screening and agree to an acceptable method of contraception.)

Exclusion Criteria:

  • History of a CDC Clinical Category C event requiring treatment (not including cutaneous Kaposi's sarcoma) within 45 days of the screening visit. Treatment for the acute event must have been completed at least 30 days before screening.
  • Subject is enrolled in one or more investigational drug studies which may impact HIV RNA suppression.
  • Subject is unable to complete the 48-week dosing period, evaluations and assessments.
  • Subject is pregnant or breastfeeding.
  • History of clinically relevant inflammation of the pancreas or hepatitis within 6 months prior to screening.
  • Subject suffers from a serious medical condition, such as diabetes or heart problem.
  • Pre-existing mental, physical, or substance abuse disorder.
  • History of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction.
  • Abnormal laboratory results within 28 days before the first dose of study medication.
  • Required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days before screening, or will need these during the study.
  • Subject requires treatment with immunomodulating drugs such as systemic corticosteroids, interleukins, vaccines, or interferons within 28 days prior to screening, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
  • Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
  • Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of screening.
  • Subject has a history of allergy to any of the study drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00046176

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Sponsors and Collaborators
ViiV Healthcare
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Publications of Results:
ABACAVIR + LAMIVUDINE FIXED DOSE COMBINATION TABLET ONCE DAILY (QD) COMPARED WITH ABACAVIR (ABC) AND LAMIVUDINE (3TC) TWICE DAILY (BID) IN HIV-1 INFECTED SUBJECTS (ESS30008). Hill-Zabala, Christina E. PharmD 1, Sosa, Nestor MD 2, DeJesus, Edwin MD 3, Herrera, Gisella MD, Florance, Allison M. MS , Watson, Maria E. PhD , and Shaefer, Mark S. PharmD (144F), 2005 Annual Meeting of the American College of Clinical Pharmacy, San Francisco, CA; USA, 10/23/2005
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
Sosa N, DeJesus E, Hill-Zabala C, et al. Abacavir + lamivudine (ABC/3TC) fixed-dose combination tablet once-daily compared with abacavir and lamivudine twice-daily in HIV-1-infected subjects over 48 weeks (ESS30008). 2th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 22-25, 2005. [poster 572]
PATIENT SATISFACTION WITH ABACAVIR (ABC)-LAMIVUDINE (3TC) FIXED DOSE COMBINATION (FDC) TABLET ONCE DAILY (QD) COMPARED WITH ABC AND 3TC TWICE DAILY (BID) IN HIV-1 INFECTED PATIENTS (ESS30008). Hill-Zabala, Christina E. PharmD , Watson, Maria E. PhD , Sosa, Nestor MD , DeJesus, Edwin MD , and Florance, Allison M. MS (145E), 2005 Annual Meeting of the American College of Clinical Pharmacy, San Francisco, CA; USA, 10/23/2005
Sosa N, DeJesus E, Hill-Zabala C, et al. Abacavir + lamivudine (ABC/3TC) fixed-dose combination tablet once-daily compared with abacavir and lamivudine twice-daily in HIV-1-infected subjects (ESS30008). 7th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, November 14-18, 2004 . [poster P45]

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Responsible Party: ViiV Healthcare Identifier: NCT00046176    
Other Study ID Numbers: ESS30008
First Posted: September 23, 2002    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by ViiV Healthcare:
HIV-1 Abacavir Lamivudine Antiretroviral-experienced
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
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