HIV PrEP Priming of Immune Effectors

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MRC/UVRI and LSHTM Uganda Research Unit; MRC/UVRI Uganda Research Unit on Aids
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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