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A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
This study has been completed.
Study NCT00046176   Information provided by GlaxoSmithKline
First Received: September 20, 2002   Last Updated: October 13, 2008   History of Changes

September 20, 2002
October 13, 2008
August 2002
 
Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. [ Time Frame: 48 weeks ]
Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.
Complete list of historical versions of study NCT00046176 on ClinicalTrials.gov Archive Site
Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance [ Time Frame: 48 weeks ]
Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance
 
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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
HIV Infection
  • Drug: abacavir/lamivudine
  • Drug: abacavir
  • Drug: lamivudine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
240
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Costa Rica,   Panama,   Puerto Rico
 
NCT00046176
Study Director, GSK
ESS30008
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP