Expired Study
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Fountain Valley, California 92708


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.


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.


Study is Available At:


Original ID:

ESS30008


NCT ID:

NCT00046176


Secondary ID:


Study Acronym:


Brief Title:

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 Antiretr


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

240


Enrollment Type:


Overall Contact Information

Official Name:GSK Clinical Trials, MD
Study Director
GlaxoSmithKline

Study Dates

Start Date:August 2002
Verification Date:May 2011
Last Changed Date:June 2, 2011
First Received Date:September 20, 2002

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:abacavir/lamivudine
Intervention Type:Drug
Name:abacavir
Intervention Type:Drug
Name:lamivudine
Other Name:abacavir

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:16280696

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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