NCT02593409

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

October 21, 2015

Last Update Submit

September 18, 2017

Conditions

HIV-1 Infections

Keywords

HIV-1pre-exposure prophylaxis (PrEP)immune response

Outcome Measures

Primary Outcomes (1)

  • Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP

    0-12 months

Secondary Outcomes (2)

  • Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 6 months on PREP

    0-6 months

  • Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between 12 months on PREP and at 18 months after PREP cessation

    12-18 months

Other Outcomes (5)

  • HIV-1 incidence.

    0-18 months

  • Viral load among participants who become infected with HIV-1 despite PREP.

    0-18 months

  • Adherence to PREP as measured by plasma sampling.

    0-18 months

  • +2 more other outcomes

Study Arms (1)

TDF/FTC

OTHER

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.

Drug: TDF/FTC

Interventions

TDF/FTCDRUG

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.

Also known as: Truvada®
TDF/FTC

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 at screening
  • not intending to move away from the clinic's catchment area for the next 2 years
  • HIV-1 antibody negative
  • reports commercial sex work
  • contact information is provided
  • written informed consent

You may not qualify if:

  • HIV infection at screening
  • participation in previous or concurrent HIV vaccine trials
  • lactating, pregnant or planning pregnancy
  • renal function impairment (serum creatinine \>1.5 mg/dl), Fanconi syndrome
  • abnormal liver function tests (AST/ALT \> 43 U/L), liver disease, viral hepatitis, hepatitis B virus (HBV) infection
  • serum phosphorus \<2.2mg/dl, osteoporosis
  • known sensitivity to components of the Truvada® formulation
  • any immunosuppressive treatment, such as systemic corticosteroids
  • assumption of medication that interacts with Truvada®
  • high likelihood of poor adherence to PREP and clinic attendance
  • any condition that in the opinion of the attending physician could endanger the health of the participant or render her unsuitable to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC/UVRI Uganda Research Unit on Aids - Good Health for Women Project

Kampala, Uganda

RECRUITING

Related Publications (1)

  • Cranage M, Sharpe S, Herrera C, Cope A, Dennis M, Berry N, Ham C, Heeney J, Rezk N, Kashuba A, Anton P, McGowan I, Shattock R. Prevention of SIV rectal transmission and priming of T cell responses in macaques after local pre-exposure application of tenofovir gel. PLoS Med. 2008 Aug 5;5(8):e157; discussion e157. doi: 10.1371/journal.pmed.0050157.

    PMID: 18684007BACKGROUND

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Pietro Pala, MD

    MRC/UVRI and LSHTM Uganda Research Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Kalanzi

CONTACT

+256417704000berna.kalanzi@mrcuganda.org

Afusa Nabuuma

CONTACT

+256417704000afusa.nabuuma@mrcuganda.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

November 2, 2015

Study Start

May 25, 2017

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

UG(1)