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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122603

Enrollment

Registered

2005-07-22

Start date

2005-12-01

Completion date

2007-08-01

Last updated

2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV Protease Inhibitors, HIV infections, Atazanavir, Saquinavir, Fosamprenavir, ritonavir, Treatment Naive

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.

Interventions

DRUGFosamprenavir

ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill twice a day) + FPV (700mg: 1 pill twice a day)

DRUGSaquinavir

ATV (150mg: 2 pills per day) + RTV (100mg: 1 pill per day) + SQV (500mg: 3 pills per day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment	—

Secondary

Measure	Time frame
Safety of protease inhibitors	—
Percentage of patients with viral load below 400 copies/ml at week 16 (W16)	—
Body mass index (BMI)	—

Countries

France

Contacts

PRINCIPAL_INVESTIGATORRoland Landman, MD

Hopital Bichat SMIT A Paris

STUDY_CHAIRJean Pierre Aboulker, MD

Inserm SC10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026