A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Infection, Human Immunodeficiency Virus I, HIV Infection

Intervention / Treatment
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* Drug: abacavir/lamivudine
* Drug: abacavir
* Drug: lamivudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: abacavir/lamivudine|nan|
|Drug: abacavir|nan|
|Drug: lamivudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks. |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 Abacavir Lamivudine Antiretroviral-experienced