Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

Study Overview
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Brief Summary
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A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.

Detailed Description
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A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 infection.

Official Title
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An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: Raltegravir
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are infected with HIV-1 Patients have not yet received any treatment for HIV Patients with HIV viral RNA exceeds 5000 copies per ml Ages at least 20 years Exclusion Criteria: Patients with acute or decompensated chronic hepatitis Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range Patients with any medical disorder that the use of study medications is contraindicated Pregnant or breastfeeding women Patients who are lack of expectation to maintain assigned study medication during study period Patients who have received therapy with investigational drugs in the previous 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Raltegravir<br>Raltegravir 400mg oral twice daily | Drug: Efavirenz<br>* Efavirenz 600mg oral at bedtime<br>* Other names: Stocrit;|
| Active Comparator: Efavirenz<br>Efavirenz 600mg oral at bedtime | Drug: Raltegravir<br>* Raltegravir 400mg oral twice daily<br>* Other names: Isentress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms. | Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms. | At week 48 of both arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms. | Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms. | At week 48 of both arms | 
| The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms. | The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms. | At week 48 of both arms. | 
| The Proportion of Treatment Failure at Week 48 for Both Arms. | The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms. | At week 48 of both arms | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efavirenz, Raltegravir, Combination antiretroviral therapy