DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a therapy with an all once daily regimen of stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.

Official Title
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Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Subjects

Conditions
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AIDS, HIV Infections

Intervention / Treatment
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* Drug: efavirenz, stavudine extended release, lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older infected with HIV and weigh at least 40 kg. Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater. Be willing to use two forms of contraception throughout study. No previous exposure to antiretroviral (ARV) drugs Exclusion Criteria: Pregnancy or breastfeeding Physical or psychiatric disability Proven or suspected acute hepatitis within 30 days prior to study entry Active AIDS-defining opportunistic infection or disease History of acute or chronic pancreatitis

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: efavirenz, stavudine extended release, lamivudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate efficacy of d4T-XR/3TC/EFV given QD determined by |  |  | 
| proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96 |  |  | 
| Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96 |  |  | 
| Determine viral suppression of plasma HIV RNA change in baseline at week 48 |  |  | 
| Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation |  |  | 
| Evaluate time to undetectable plasma HIV RNA |  |  | 
| Evaluate proportion of patients demonstrating virologic breakthrough |  |  | 
| Evaluate proportion of patients demonstrating virologic failure |  |  | 
| Evaluate time to virologic breakthrough and virologic failure |  |  | 
| Measure magnitude and durability of changes in CD4 cell counts |  |  | 
| Evaluate patient adherence with QD regimen using pill counts and AMAF |  |  | 
| Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure |  |  | 
| Explore QoL changes using MOS-HIV health survey |  |  | 
| Evaluate safety and tolerability of QD regimen |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS