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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046176
First received: September 20, 2002
Last updated: June 2, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Infection, Human Immunodeficiency Virus I
HIV Infection
Drug: abacavir/lamivudine
Drug: abacavir
Drug: lamivudine
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: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Estimated Enrollment: 240
Study Start Date: August 2002
Intervention Details:
    Drug: abacavir/lamivudine Drug: abacavir Drug: lamivudine
    Other Names:
    • abacavir
    • lamivudine
    • abacavir/lamivudine
  Eligibility

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

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.
  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: NCT00046176

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
Los Angeles, California, United States, 90028
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Sacramento, California, United States, 95825
GSK Investigational Site
San Francisco, California, United States, 94115-1931
GSK Investigational Site
Torrance, California, United States, 90502
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
GSK Investigational Site
Denver, Colorado, United States, 80205
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
GSK Investigational Site
Washington, District of Columbia, United States, 20009
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, Florida, United States, 33136
GSK Investigational Site
Miami, Florida, United States, 33133
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
GSK Investigational Site
Tampa, Florida, United States, 33614
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Atlanta, Georgia, United States, 30339
GSK Investigational Site
Augusta, Georgia, United States, 30912
GSK Investigational Site
Decatur, Georgia, United States, 30033
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67214
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, New Jersey
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
United States, New York
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10014
GSK Investigational Site
New York, New York, United States, 10019
GSK Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Greenville, North Carolina, United States, 27858
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
United States, Oklahoma
GSK Investigational Site
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
GSK Investigational Site
Reading, Pennsylvania, United States, 19601
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75208
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dallas, Texas, United States, 75219
GSK Investigational Site
Houston, Texas, United States, 77004
GSK Investigational Site
Houston, Texas, United States, 77027
United States, Virginia
GSK Investigational Site
Hampton, Virginia, United States, 23666
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Panama
GSK Investigational Site
Panama City, Panamá, Panama
Puerto Rico
GSK Investigational Site
Ponce, Puerto Rico, 00731
GSK Investigational Site
Rio Piedras, Puerto Rico, 925
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications:
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]

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00046176     History of Changes
Other Study ID Numbers: ESS30008
Study First Received: September 20, 2002
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV-1 Abacavir Lamivudine Antiretroviral-experienced

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
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 28, 2014