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Impact of HIV Drug Resistance Testing, and Subsequent Change to an Individualized Therapy in Tanzania

NCT03557021 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2018-06-14

No results posted yet for this study

Summary

The current therapy regimens in Sub-Saharan countries, consisting of standardized first and second line drug combinations, yield a high rate of treatment failure, even within the first 12 months of therapy (23). These and other facts hint at the need for HIV resistance testing to improve treatment outcomes in resource-limited settings, but no prospective clinical data about this intervention exists. The proposed study aims to evaluate the impact of HIV drug resistance testing, and subsequent change to an individualized (second-line) therapy based on the resistance profile, in Tanzanian patients (children, adolescents and adults) with virological failure of their first-line and second-line therapy. Additionally, prevalence, patterns and clinical impact of HIVDR will be assessed, as well as the effect of enhanced adherence counselling.

The results of this study will help doctors to take evidence-based diagnostic and therapeutic decisions at an individual level, and will inform policy-makers in their decisions about future treatment and management concepts for HIV/AIDS.

Conditions

  • HIV Drug Resistance

Interventions

DIAGNOSTIC_TEST

HIV Drug resistance testing

HIV Drug resistance testing by HIV pro DNA sanger sequencing

Sponsors & Collaborators

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Medical Mission Institute, Germany

    lead OTHER

Principal Investigators

  • John Changalucha, MD · National Institute of Medical research Mwanza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-09-30
Completion
2020-09-30

Countries

  • Tanzania

Study Locations

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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 NCT03557021 on ClinicalTrials.gov