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Resistance Testing to Improve Management of Virologic Failure in Sub-Saharan Africa (REVAMP)

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ClinicalTrials.gov Identifier: NCT02787499
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Mbarara University of Science and Technology
University of KwaZulu
Emory University
University of Rochester
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Mark Siedner, Massachusetts General Hospital

Brief Summary:
The study design is an open-label, randomized controlled trial. The study will be conducted at study sites in Uganda and South Africa. The study population will include HIV-infected patients on first-line antiretroviral therapy with a recent viral load >1,000 copies/milliliter (or dried blood spot viral load >1,000 copies/milliliter). Eligible participants will be randomized to the WHO-based standard of care for management of virologic failure or immediate resistance testing to guide ART regimen decisions. The primary outcome of interest will be viral suppression (<200 copies/mL) at 9 months after study enrollment, and will be assessed using an intention to treat analysis, where missing or absent results will be considered failures. Secondary outcomes of interest will be viral suppression below the limit of assay detection, viral suppression on continuation of first-line (non-nucleoside reverse transcriptase inhibitor [NNRTI]-based) therapy, drug resistance at study conclusion, and mortality, among others. The overarching goal of this study is to determine whether addition of routine resistance testing, to guide management of virologic failure and sustain the successful completion of the HIV continuum of care, improves clinical outcomes and reduces costs for patients with virologic failure on first-line therapy in sub-Saharan Africa.

Condition or disease Intervention/treatment Phase
HIV AIDS Procedure: HIV-1 RNA Resistance Testing Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Resistance Testing Versus Adherence Support for Management of Patients With Virologic Failure on First-Line Antiretroviral Therapy in Sub-Saharan Africa
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Standard of Care
Follows the 2013 World Health Organization (WHO) HIV treatment guidelines. Study participants will receive adherence support and return for a repeat viral load test in 3 months (or in 1 month for pregnant participants). Treatment failure will be defined by two consecutive viral load measurements greater than 1,000 copies/mL. Participants who meet this criteria will be switched to second-line therapy. Those with a viral load <1,000 copies/mL at repeat testing will be retained on first-line therapy.
Experimental: HIV-1 RNA Resistance Testing
Participants will receive HIV-1 RNA drug resistance testing at study enrollment. ART treatment regimen decisions will be determined based on the results of resistance testing.
Procedure: HIV-1 RNA Resistance Testing
Perform drug resistance on enrollment to guide management of virologic failure




Primary Outcome Measures :
  1. Virologic resuppression [ Time Frame: 9 months ]
    Detectable viral load < 200 copies/mL


Secondary Outcome Measures :
  1. Proportion of patients with an undetectable viral load (below limit of detection) at study conclusion [ Time Frame: 9 months ]
  2. Proportion of patients with an undetectable viral load on first-line (NNRTI-based) therapy at study conclusion [ Time Frame: 9 months ]
  3. Proportion of patients with International AIDS Society-defined drug resistance mutations to their current regimen. As part of this analysis, we will also evaluate for minority drug resistance [ Time Frame: 9 months ]
  4. Total patient care costs, including diagnostic testing and ART costs for the study duration [ Time Frame: 9 months ]
  5. Retention in HIV clinical care at study completion [ Time Frame: 9 months ]
  6. 9-month mortality rate [ Time Frame: 9 months ]
  7. Change in health-related quality of life from baseline to 9 months [ Time Frame: 9 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In care at a public HIV clinic within a PEPFAR-focus sub-Saharan African country (South Africa or Uganda) and living within 100 kilometers of the clinic
  • Age ≥ 18 years at the time of enrollment
  • Currently prescribed first-line (non-nucleoside reverse transcriptase inhibitor [NNRTI]-based) ART for at least 5 months. Switches within first line regimens, including NNRTI and nucleos(t)ide backbone changes are allowed.
  • Detectable plasma viral load > 1,000 copies/mL or dried blood spot viral load > 1,000 copies/mL within 90 days of enrollment

Exclusion Criteria:

  • Known prior drug resistance
  • Prior exposure to PI-based ART
  • Current clinical indication to start PI-based ART
  • Not planning to remain in the clinic catchment area for the next nine months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787499


Contacts
Contact: Mark Siedner, MD MPH 1-617-726-4686 msiedner@mgh.harvard.edu

Locations
South Africa
University of Kwa-Zulu Natal Recruiting
Durban, South Africa
Contact: Yunus Moosa       Moosay@ukzn.ac.za   
Uganda
Mbarara University of Science and Technology Recruiting
Mbarara, Uganda
Contact: Bosco Bwana       mwebesa@bwana@yahoo.com   
Sponsors and Collaborators
Massachusetts General Hospital
Mbarara University of Science and Technology
University of KwaZulu
Emory University
University of Rochester
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Mwebesa Bwana, MBChB MPH Mbarara University of Science and Technology
Principal Investigator: Yunus Moosa, MBChB PhD University of KwaZulu

Responsible Party: Mark Siedner, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02787499     History of Changes
Other Study ID Numbers: 2016P000589
R01AI124718 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made public and accessible through request after completion of primary analysis.

Keywords provided by Mark Siedner, Massachusetts General Hospital:
Drug resistance
Standard of care
sub-saharan africa
antiretroviral therapy
diagnostics
implementation