MedTrace Logo

Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy

NCT01694017 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2014-11-24

No results posted yet for this study

Summary

The purpose of this study is to compare clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. The first step will be empirical data collection for one year for calculating the incremental cost effectiveness ratio (ICER). The second step will be to perform a simulation model for calculating long term ICER.

Conditions

Interventions

DRUG

Tenofovir

tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year

DRUG

Zidovudine

zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year

Sponsors & Collaborators

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • Tufts University

    lead OTHER

Principal Investigators

  • Christine C Wanke, MD · Tufts University

  • Sowmyanarayanan V Thuppal, MD · Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT01694017 on ClinicalTrials.gov