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Pre-Exposure Prophylaxis Using TMC278LA

NCT01049932 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2010-08-16

No results posted yet for this study

Summary

Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection.

The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.

Conditions

  • HIV Infections

Interventions

DRUG

TMC278LA

TMC278LA 600mg injected intramuscularly (i/m)

Sponsors & Collaborators

  • St Stephens Aids Trust

    lead OTHER

Principal Investigators

  • Marta Boffito, Dr · St Stephen's AIDS Trust (London)

  • Akil Jackson, Dr · St Stephen's AIDS Trust (London)

  • Martin Fisher, Dr · Royal Sussex County Hospital, Brighton

  • Alan Winston, Dr · St Mary's Hospital, London

  • Julie Fox, Dr · St. Thomas's Hospital (London)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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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 NCT01049932 on ClinicalTrials.gov