Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients.

Detailed Description
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The purpose of this randomized, open-label study is to evaluate virological efficacy and safety of two double protease inhibitor regimens: atazanavir/fosamprenavir/ritonavir 300 mg once daily/ 700/100 mg twice daily, versus atazanavir/saquinavir/ritonavir 300/1500/100 mg once daily in protease inhibitor naive HIV-1 patients. Patients with CD4 cell counts over or equal to 200/mm3, HIV viral load between 10,000 and 750,000 copies per milliliter, and wild-type genotype at baseline will be eligible. This multicenter study will enroll 60 patients (n=30 in each group). The planned duration of the study is 48 weeks from the enrolment of the last subject. The primary efficacy endpoint will be virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment. The durability of this response will be evaluated and patients will be followed for 48 weeks. The primary safety endpoint will be treatment interruptions because of adverse effects.

Official Title
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Efficacy and Safety of Regimens Restricted to a Combination of Two Boosted Protease Inhibitors as Potent Antiretroviral Therapy in HIV-1 Infected Patients. ANRS 127 2IP

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Fosamprenavir
* Drug: Saquinavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Protease inhibitor naive patients Wild type genotype CD4 greater than 200/mm3 Viral load between 10,000 copies/ml and 750,000 copies/ml Signed informed consent Exclusion Criteria: Pregnancy; breast feeding Antiretroviral (ARV) pretreated patients Hyperlipidemic treatment Evolutive disease

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Atazanavir + Fosamprenavir + ritonavir | Drug: Fosamprenavir<br>* ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)<br>|
| Experimental: group 2<br>Atazanavir + saquinavir + ritonavir | Drug: Saquinavir<br>* ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of protease inhibitors |  |  | 
| Percentage of patients with viral load below 400 copies/ml at week 16 (W16) |  |  | 
| Body mass index (BMI) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Protease Inhibitors, HIV infections, Atazanavir, Saquinavir, Fosamprenavir, ritonavir, Treatment Naive