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Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection

NCT03205566 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-03-16

Study results available
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Summary

This study evaluates whether a 7-day course of Raltegravir 400mg bd or Raltegravir 400mg/lamivudine 150mg bd can prevent HIV from infecting genital tissue and will relate the level of drug in the blood to the level of drug in genital tissue and to the ability to of HIV to infect genital tissue. As well as determining whether these regimes can provide ex vivo protection against HIV, this study will also determine speed to provision of protection and a 48 hour PK/PD decay profile of Raltegravir following drug cessation after attaining steady state concentrations. The results will also inform all future HIV pre-exposure prophylaxis studies of Raltegravir and form the basis for large scale clinical trials without the need for tissue sampling. To date, efficacy studies assessing PrEP regimens have utilized HIV-acquisition endpoints with the consequence being such studies are required to be large in subject number in order to power observations. In addition the study will provide for the first time data on HIV protection rather than just Raltegravir drug levels in tissue, and allow assessment of the possibility of Raltegravir being used as an intermittent dosing regimen in PrEP.

Conditions

Interventions

DRUG

Raltegravir 400Mg Tab

bd for 7 days

DRUG

Lamivudine 150Mg Tablet

\+ Raltegravir 400Mg tablet bd for 7 days

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Julie Fox · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2018-09-24
Completion
2018-09-24

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205566 on ClinicalTrials.gov