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

NCT03557021 | Unknown DMC

• 1 other identifier: HIVDR2
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Viral Load

  Viral load will be measured by plasma HIV viral load measurement (copies per ml) after switching first-line treatment failure patients to individualized therapy compared to standard second line therapy.

  12 month

Secondary Outcomes (5)

• Incidence of HIV related adverse events at 6 month

  6 month

• Incidence of HIV related adverse events at at 12 month

  12 month

• Prevalence of HIV Drug resistance mutations

  study start

• Pattern of HIV Drug resistance mutations

  study start

• Viral load at 3th month

  3 month

Study Arms (2)

Individualized therapy arm

EXPERIMENTAL

HIV Treatment failure patients will undergo an HIV Drug resistance testing and the followed therapy will be adjusted with in this setting available medications to the outcome of the resistance profile

Diagnostic Test: HIV Drug resistance testing

standard therapy arm

ACTIVE COMPARATOR

HIV Treatment failure patients will undergo an HIV Drug resistance testing and the national defined standard therapy will be applied as second line treatment.

Diagnostic Test: HIV Drug resistance testing

Interventions

HIV Drug resistance testing DIAGNOSTIC_TEST

HIV Drug resistance testing by HIV pro DNA sanger sequencing

Individualized therapy arm; standard therapy arm

Eligibility Criteria

• Age: 1 Month - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed HIV positive patients on first-line ART
• Virological treatment failure with \> 1000 copies/ ml

You may not qualify if:

• No consent given
• HIV patients with psychiatric disorders

Sponsors & Collaborators

• Medical Mission Institute, Germany: lead
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (3)

PASADA

Dar es Salaam, Tanzania

RECRUITING

Baylor Hospital

Mwanza, Tanzania

NOT YET RECRUITING

Bugando Medical Center

Mwanza, Tanzania

RECRUITING

Study Officials

• John Changalucha, MD

  National Institute of Medical research Mwanza

  STUDY CHAIR

Central Study Contacts

Christa Kasang, PhD

CONTACT

+4993180485; christa.kasang@medmissio.de

Daniel Magesa, MD

CONTACT

+255754307750; djnmagesa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Case control study

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: June 14, 2018
• Study Start: July 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2020
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

TA (3)