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 range
18 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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