A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients
Phase 3
Completed
- Conditions
- HIV InfectionInfection, Human Immunodeficiency Virus I
- Registration Number
- NCT00046176
- Lead Sponsor
- ViiV Healthcare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. 48 weeks
- Secondary Outcome Measures
Name Time Method Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance 48 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇵🇷Rio Piedras, Puerto Rico