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Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

NCT01003990 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2017-05-11

Study results available
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Summary

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Conditions

Interventions

DRUG

Atazanavir

Tablets, Oral, 400 mg, once daily, indefinitely

DRUG

Atazanavir/Ritonavir

Tablets, Oral, 300/100 mg, once daily, indefinitely

DRUG

Tenofovir/Emtricitabine

Tablets, Oral, 300/200 mg, once daily, indefinitely

DRUG

Lopinavir/ritonavir

Tablets, Oral, 400/100 mg, twice daily, indefinitely

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • Dominican Republic
  • France
  • Guatemala
  • Hungary
  • Indonesia
  • Italy
  • Malaysia
  • Mexico
  • Panama
  • Peru
  • Portugal
  • Puerto Rico
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
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 NCT01003990 on ClinicalTrials.gov