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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02593409 |
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Date of registration:
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21/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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HIV PrEP Priming of Immune Effectors
PREPPIE |
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Scientific title:
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HIV Pre-Exposure Prophylaxis Priming of Immune Effectors |
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Date of first enrolment:
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May 25, 2017 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02593409 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Uganda
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Contacts
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Name:
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Pietro Pala, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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MRC/UVRI Uganda Research Unit on Aids |
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Name:
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Berna Kalanzi |
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Address:
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Telephone:
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256417704000 |
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Email:
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Berna.Kalanzi@mrcuganda.org |
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Affiliation:
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Name:
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Berna Kalanzi |
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Address:
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Telephone:
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+256417704000 |
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Email:
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berna.kalanzi@mrcuganda.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV-1 Infections
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Intervention(s)
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Drug: TDF/FTC
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Primary Outcome(s)
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Change in IFN-? ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP
[Time Frame: 0-12 months]
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Secondary Outcome(s)
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Change in IFN-? ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 6 months on PREP
[Time Frame: 0-6 months]
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Change in IFN-? ELISPOT response to HIV-1 peptides in persistently uninfected individuals between 12 months on PREP and at 18 months after PREP cessation
[Time Frame: 12-18 months]
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Secondary ID(s)
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PREPPIE001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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