a hiv study of a fixed-dose combination tablet in antiretroviral experienced patients

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

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.


Eligibility 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.

Keywords: hiv-1 abacavir lamivudine antiretroviral-experienced