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Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)

NCT00207142 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2010-01-12

Study results available
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Summary

The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

Conditions

  • HIV Infections

Interventions

DRUG

Atazanavir + 2 NRTIs

Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

DRUG

Atazanavir + Ritonavir + 2 NRTIs

Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-08-31
Completion
2008-01-31

Countries

  • Estonia
  • France
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Portugal
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00207142 on ClinicalTrials.gov