HIV PrEP Priming of Immune Effectors (NCT02593409) | Clinical Trial Compass
UnknownPhase 4
HIV PrEP Priming of Immune Effectors
Uganda220 participantsStarted 2017-05-25
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in IFN-γ ELISPOT response to HIV-1 peptides in persistently uninfected individuals between baseline and 12 months on PREP