Clinical trial NCT00046176: A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Keywords: HIV-1 Abacavir Lamivudine Antiretroviral-experienced
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2002-09-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.
timeFrame: 48 weeks
Secondary outcomes:
measure: Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Hillsborough
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Somers Point
country: United States
facility: GSK Investigational Site
state: New Jersey
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Stony Brook
country: United States
facility: GSK Investigational Site
state: New York
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Hershey
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Hampton
country: United States
facility: GSK Investigational Site
state: Virginia
city: San Jose
country: Costa Rica
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Rio Piedras
country: Puerto Rico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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
citation: 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]
citation: 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
citation: 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.
citation: 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]