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

HIV Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046176
• Other study ID #: ESS30008
• Status: Completed
• Phase: Phase 3
• Start date: August 26, 2002
• Est. completion date: May 17, 2004

Study information

• Verified date: March 2020
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 17, 2004
• Est. primary completion date: May 17, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection
• Infection, Human Immunodeficiency Virus I

Intervention

Drug:
• abacavir/lamivudine

• abacavir

• lamivudine

Locations

Country	Name	City	State
Costa Rica	GSK Investigational Site	San Jose
Panama	GSK Investigational Site	Panama City
Puerto Rico	GSK Investigational Site	Ponce
Puerto Rico	GSK Investigational Site	Rio Piedras
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hillsborough	New Jersey
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Reading	Pennsylvania
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Stony Brook	New York
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
ViiV Healthcare

Countries where clinical trial is conducted

United States,  Costa Rica,  Panama,  Puerto Rico, 

References & Publications (6)

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, Herr

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., LaMarc

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

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 In

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 Opp

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, SEA — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.		48 weeks
Secondary	Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance		48 weeks