Dolutegravir in Reservoirs

Phase 4 Terminated 22 enrolled Emory University National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to find out how well the HIV medication dolutegravir gets into different parts of the body including blood plasma, special blood cells, and rectal tissue. Specifically, investigators want to compare how fast dolutegravir lowers the HIV viral load in these three different sites. In addition, as an exploratory aim, investigators seek to learn if there are any differences in how dolutegravir acts in males and females. Results of this study will provide more information about HIV medications and their limitations. In the future, this could help create better HIV medications that can get into these hard-to-reach places and eventually cure HIV infection.

Timeline

Start: 2016-09
Primary completion: 2019-09-11
Completion: 2019-09-11

Outcome

Outcome not reported

Stopped (Enrollment): “This study terminated early due to the ongoing covid-19 pandemic making it unsafe to recruit participants for in-person visits. Participants are living with HIV who are antiretroviral therapy-naive and are at high risk of COVID-19 complications.”

Publications

Results Lahiri CD, Brown NL, Ryan KJ, Acosta EP, Sheth AN, Mehta CC, Ingersoll J, Ofotokun I. HIV RNA persists in rectal tissue despite rapid plasma virologic suppression with dolutegravir-based therapy. AIDS. 2018 Sep 24;32(15):2151-2159. doi: 10.1097/QAD.0000000000001945.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dolutegravir	Other / unclassified	50 mg	Oral
Background	Triumeq	Unknown	50 mg	Oral
Background	Triumeq	Unknown	300 mg	Oral
Background	Triumeq	Unknown	600 mg	Oral
Background	Truvada	Unknown	200 mg	Oral
Background	Truvada	Unknown	300 mg	Oral