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

This study has been completed.
Sponsor:
Collaborators:
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

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
 Saquinavir
Fosamprenavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013