Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa: A Prospective Observational Cohort Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

This is a prospective observational cohort study enrolling participants in South Africa and Uganda who are prescribed an HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir, which is known as TLD. We hope to better understand how effective TLD will be in sub-Saharan Africa. If treatment failure occurs, we seek to understand the possible reasons, including drug resistance and adherence challenges.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Age ≥18 years

• HIV-positive and in care at one of the study clinics

• Current use of NNRTI-based, first-line ART for a minimum of 6 months

• Prescribed change to TLD by clinic staff

• Residing within 100 kilometers of the treatment clinic without plans to change permanent residence in the next 48 weeks

• Consents to participation

Locations
Other Locations
South Africa
Africa Health Research Institute
Recruiting
Somkele
Uganda
Mbarara University of Science and Technology
Active, not recruiting
Mbarara
Contact Information
Primary
Suzanne M McCluskey, MD
smccluskey@mgh.harvard.edu
617-726-9488
Time Frame
Start Date: May 14, 2019
Estimated Completion Date: June 1, 2023
Participants
Target number of participants: 1000
Treatments
Study Population
The study will enroll a total of 1,000 ART-experienced participants from the study sites in Uganda and South Africa who are being transitioned to TLD from non-nucleoside reverse transcriptase-based antiretroviral therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Wellcome Trust, Africa Health Research Institute, National Institute of Allergy and Infectious Diseases (NIAID), Harvard Medical School (HMS and HSDM), Emory University, ViiV Healthcare, Mbarara University of Science and Technology, University of KwaZulu
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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