Dolutegravir in Reservoirs

• Status: Terminated
• Trial end date: 2019-09-11
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Treatments: Anti-Retroviral Agents; Dolutegravir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Triumeq

Criteria

Inclusion Criteria:

• No ARVs in the last 6 months (from date of screening)

• No documented or suspected resistance to integrase inhibitors (dolutegravir, elvitegravir, raltegravir, or bictegravir).

• Creatinine Clearance >50 mL/min, as calculated by the Cockcroft-Gault equation within 90 days of screen

• Liver function testing, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase < 5 times upper limit of normal within 90 days of screen

• Intact gastrointestinal tract

• Able and willing to give informed consent

• Willing and eligible to initiate ARV therapy with Triumeq, DTG + Truvada (TDF/FTC), or DTG + Descovy (FTC/TAF)

• Agree to receive from their provider and pay for a prescribed supply of the drug, Tivicay® (dolutegravir/DTG), with either Triumeq, or Truvada or Descovy as determined by their primary HIV provider

• Agree to take the prescribed medication by mouth

• Agree that they (the participant) is responsible for bringing these medications with them to their study visits

• Willing to undergo serial blood and rectal tissue sampling

• Female participants' must be willing to have a pregnancy test done at each visit. Female participants of childbearing potential (FCB) must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable form of birth control such as oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, permanent sterilization, or another acceptable method, as determined by the investigator for the duration of the study. FCB are defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy or have not been naturally postmenopausal for at least 24 consecutive months (i.e have had menses at any time in preceding 24 months)

Exclusion Criteria:

• Pregnant or attempting to conceive now or during the course of the study

• Self-reported or documented current anal or rectal disease prohibiting safe anoscopy and biopsies, in investigator's opinion.

• Taking concurrent medications that interfere with DTG

• Bleeding diathesis

• Platelet count <50,000 mm3

• Medical condition that interferes with conduct of study, in investigator's opinion