NCT04050449

Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of TLD

Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance Following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD) for First- or Second-Line ART or With Rifampin-Containing TB Treatment: The Hakim Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,339 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

Tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) is being used more widely across the world to treat HIV. This is an observational study (a type of study in which participants are observed and certain outcomes are measured). The aim of this study is to observe how successful TLD is at treating HIV, in the following groups of people: * People switching to TLD, after taking anti-HIV medication that contains a nonnucleoside reverse transcriptase inhibitor (NNRTI) drug (such as Efavirenz or Nevirapine) (Group 1). * People switching to TLD, after taking anti-HIV medication that contains a boosted protease inhibitor (PI) drug (such as Lopinavir or Atazanavir) (Group 2). * People taking TLD and receiving medication for TB that includes the drug rifampicin (RIF) (Group 3). These people must be starting one or both of these medications when they enter the study. * People starting TLD who have not taken anti-HIV medication before (Group 4). Another goal of this study is to use genetic testing of the virus (HIV) to see how often HIV is resistant to TLD. Genetic testing of the virus is one way to see if the TLD medication is not working to treat a person's HIV infection.

Conditions

• HIV-1-infection

Timeline

• Start date: 2019-10-28
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2019-08-08
• Last updated: 2023-08-21

Locations

14 sites across 6 countries: Haiti, Kenya, Malawi, South Africa, Uganda, Zimbabwe