Clinical trial NCT00122603: Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV Protease Inhibitors
HIV infections
Atazanavir
Saquinavir
Fosamprenavir
ritonavir
Treatment Naive
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
Collaborators: name: Bristol-Myers Squibb
name: GlaxoSmithKline
name: Hoffmann-La Roche
First posted: 2005-07-22
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Secondary outcomes:
measure: Safety of protease inhibitors
measure: Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
measure: Body mass index (BMI)
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard
Study officials:
affiliation: Hopital Bichat SMIT A Paris
name: Roland Landman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm SC10
name: Jean Pierre Aboulker, MD
role: STUDY_CHAIR
References:
citation: Landman R, Capitant C, Descamps D, Chazallon C, Peytavin G, Katlama C, Pialoux G, Bentata M, Brun-Vezinet F, Aboulker JP, Yeni P; ANRS 127 Study Group. Efficacy and safety of ritonavir-boosted dual protease inhibitor therapy in antiretroviral-naive HIV-1-infected patients: the 2IP ANRS 127 study. J Antimicrob Chemother. 2009 Jul;64(1):118-25. doi: 10.1093/jac/dkp146. Epub 2009 May 6.