NCT00122603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 2, 2026

Status Verified

December 1, 2011

First QC Date

July 19, 2005

Last Update Submit

April 1, 2026

Conditions

HIV Infections

Keywords

HIV Protease InhibitorsHIV infectionsAtazanavirSaquinavirFosamprenavirritonavirTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Virologic success defined as HIV RNA levels below 50 copies/ml after 16 weeks of initial treatment

Secondary Outcomes (3)

  • Safety of protease inhibitors

  • Percentage of patients with viral load below 400 copies/ml at week 16 (W16)

  • Body mass index (BMI)

Study Arms (2)

Group 1

EXPERIMENTAL

Atazanavir + Fosamprenavir + ritonavir

Drug: Fosamprenavir

group 2

EXPERIMENTAL

Atazanavir + saquinavir + ritonavir

Drug: Saquinavir

Interventions

FosamprenavirDRUG

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

Group 1
SaquinavirDRUG

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

group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy; breast feeding
  • Antiretroviral (ARV) pretreated patients
  • Hyperlipidemic treatment
  • Evolutive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des Maladies infectieuses et tropicales Hopital Bichat Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

  • 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.

    PMID: 19420019DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

fosamprenavirSaquinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolines

Study Officials

  • Roland Landman, MD

    Hopital Bichat SMIT A Paris

    PRINCIPAL INVESTIGATOR

  • Jean Pierre Aboulker, MD

    Inserm SC10

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2005

First Posted

July 22, 2005

Study Start

December 1, 2005

Study Completion

August 1, 2007

Last Updated

April 2, 2026

Record last verified: 2011-12

Locations

FR(1)