DART I - 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 efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) 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 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients

Conditions
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HIV Infections, AIDS

Intervention / Treatment
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* Drug: efavirenz; didanosine EC; 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; didanosine EC; lamivudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 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 proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96 |  |  | 
| Determine viral suppression of plasma HIV RNA from change in baseline at week 48 |  |  | 
| Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks |  |  | 
| 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 patients 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