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HIV PrEP Priming of Immune Effectors

NCT02593409 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2017-09-19

No results posted yet for this study

Summary

Can HIV-specific immunity develop in HIV uninfected humans exposed to HIV whilst receiving antiretroviral pre-exposure prophylaxis (PrEP)? Investigators will investigate this possibility in commercial sex workers in Kampala who will be receiving Truvada PrEP for one year.

Conditions

  • HIV-1 Infections

Interventions

DRUG

TDF/FTC

All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.

Sponsors & Collaborators

  • MRC/UVRI and LSHTM Uganda Research Unit

    lead OTHER

Principal Investigators

  • Pietro Pala, MD · MRC/UVRI and LSHTM Uganda Research Unit

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2018-04-30
Completion
2018-06-30
FDA Drug
Yes

Countries

  • Uganda

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 NCT02593409 on ClinicalTrials.gov