| 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
|
| |
| |
| |
| 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 |