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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Infection, Human Immunodeficiency Virus I
• Intervention / Treatment: Drug: lamivudine; Drug: abacavir; Drug: abacavir/lamivudine

• Study Type: Interventional
• Enrollment: 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Costa Rica
  • San Jose, Costa Rica
    • GSK Investigational Site
• Panama
  • Panama City, Panama
    • GSK Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 00731
    • GSK Investigational Site
  • Rio Piedras, Puerto Rico, 925
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • GSK Investigational Site
    • Long Beach, California, United States, 90813
      • GSK Investigational Site
    • Los Angeles, California, United States, 90033
      • GSK Investigational Site
    • Los Angeles, California, United States, 90028
      • 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
      • GSK Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80220
      • GSK Investigational Site
    • Denver, Colorado, United States, 80205
      • GSK Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • GSK Investigational Site
    • Washington, District of Columbia, United States, 20009
      • GSK Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • 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, 32804
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Plantation, Florida, United States, 33317
      • GSK Investigational Site
    • Tampa, Florida, United States, 33614
      • GSK Investigational Site
    • Tampa, Florida, United States, 33602
      • GSK Investigational Site
  • Georgia
    • 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
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • GSK Investigational Site
    • Somers Point, New Jersey, United States, 08244
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10014
      • GSK Investigational Site
    • New York, New York, United States, 10011
      • GSK Investigational Site
    • New York, New York, United States, 10019
      • GSK Investigational Site
    • Stony Brook, New York, United States, 11794
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • GSK Investigational Site
    • Durham, North Carolina, United States, 27710
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 27858
      • GSK Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44304
      • GSK Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • GSK Investigational Site
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • GSK Investigational Site
    • Reading, Pennsylvania, United States, 19601
      • GSK Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29206-4713
      • GSK Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • GSK Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75208
      • GSK Investigational Site
    • Dallas, Texas, United States, 75204
      • GSK Investigational Site
    • Dallas, Texas, United States, 75219
      • GSK Investigational Site
    • Houston, Texas, United States, 77027
      • GSK Investigational Site
    • Houston, Texas, United States, 77004
      • GSK Investigational Site
  • Virginia
    • Hampton, Virginia, United States, 23666
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance	48 weeks

Collaborators and Investigators

• Sponsor: ViiV Healthcare

Publications and helpful links

General 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, Hill-Zabala C, Dejesus E, Herrera G, Florance A, Watson M, Vavro C, Shaefer M. Abacavir and lamivudine fixed-dose combination tablet once daily compared with abacavir and lamivudine twice daily in HIV-infected patients over 48 weeks (ESS30008, SEAL). J Acquir Immune Defic Syndr. 2005 Dec 1;40(4):422-7. doi: 10.1097/01.qai.0000184859.24071.bd.
• 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]

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2002
• Primary Completion (Actual): May 17, 2004
• Study Completion (Actual): May 17, 2004

Study Registration Dates

• First Submitted: September 20, 2002
• First Submitted That Met QC Criteria: September 20, 2002
• First Posted (Estimate): September 23, 2002

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: HIV-1 Abacavir Lamivudine Antiretroviral-experienced
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Lamivudine; Abacavir; Dideoxynucleosides
• Other Study ID Numbers: ESS30008