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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Bristol-Myers Squibb
GlaxoSmithKline
Hoffmann-La Roche

Information provided by (Responsible Party)
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier
NCT00122603

First received: July 19, 2005
Last updated: December 21, 2011
Last Verified: December 2011
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Fosamprenavir
Drug : Saquinavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment
Secondary Outcome Measures:
  • Safety of protease inhibitors
  • Percentage of patients with viral load below 400 copies/ml at week 16 (W16)
  • Body mass index (BMI)

Enrollment: 61
Study Start Date: December 2005
Study Completion Date: August 2007

Arms Assigned Interventions
Experimental: Group 1
Atazanavir + Fosamprenavir + ritonavir
Drug: Fosamprenavir

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

Experimental: group 2
Atazanavir + saquinavir + ritonavir
Drug: Saquinavir

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122603

Locations

France
Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard
Paris, France, 75018

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
Bristol-Myers Squibb
GlaxoSmithKline
Hoffmann-La Roche

Investigators

Principal Investigator: Roland Landman, MD Hopital Bichat SMIT A Paris
Study Chair: Jean Pierre Aboulker, MD Inserm SC10
More Information

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00122603   History of Changes  
Other Study ID Numbers: 2005-003470-20  
  ANRS 127 2 IP  
Study First Received: July 19, 2005  
Last Updated: December 21, 2011  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV Protease Inhibitors
HIV infections
Atazanavir
Saquinavir
Fosamprenavir
ritonavir
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Ritonavir
Atazanavir Sulfate
HIV Protease Inhibitors
Saquinavir
Fosamprenavir
Protease Inhibitors

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.