API clinical trial dataset

Description

The dataset includes immune readouts for API trial assessing the impact of antimicrobial treatments on penile ex vivo HIV susceptibility and immunology. This phase 1/2 clinical trial randomized HIV-uninfected Ugandan men (n=125) to either oral tinidazole, topical metronidazole, topical clindamycin or topical hydrogen peroxide to define impact on ex vivo foreskin HIV susceptibility, penile immunology and BASIC species density. Details are provided at ClinicalTrials.gov #NCT03412071. Groups within the dataset are as follows: 1=control, 2=oral tinidazole, 3=topical clindamycin, 4=topical hydrogen peroxide, 5=topical metronidazole.

Steps to reproduce

Study design. This was a registered, open label, randomized clinical trial (ClinicalTrials.gov #NCT03412071) that enrolled participants from December 2017 to November 2018 through the UVRI-IAVI HIV Vaccine Program and Entebbe General Hospital in Uganda. Study participants. Participants were 125 HIV-negative uncircumcised Ugandan males seeking VMMC at Entebbe General Hospital for HIV prevention, who were willing to consent to a four-week delay in surgery and random assignment of a treatment intervention. Inclusion criteria were lack of circumcision, age >18 years, HIV seronegative, no symptoms or signs of a sexually transmitted infection, and availability for the duration of the study period (4 weeks). Eligible, consenting men were randomized to one of five groups (n=25/group): (i) control, receiving immediate circumcision, and four intervention groups that deferred surgery for 4 weeks while receiving either (ii) oral tinidazole (TZ) 2g by mouth daily for two days, or topical (iii) 0.75% metronidazole gel (MTZ), (iv) 2% clindamycin cream (CDM) or (v) 1% hydrogen peroxide gel (HP), applied underneath the foreskin twice daily for the first week then twice weekly for three weeks. Outcomes. The primary endpoint was ex vivo HIV entry into inner foreskin-derived CD4+ T cells, using a previously-validated clade A HIV pseudovirus entry assay. The sample size of 25 participants per study group provided 80% power to identify reduced virus entry by ≥33%. Predefined secondary endpoints included treatment acceptability and effects on the penile immune milieu, bacteria, epithelial integrity, and T cell subset proportion and density. Experimental details of immune and microbial assays are provided in the published protocol [Galiwango R et al, Trials. 2019:20, 443. doi.org/10.1186/s13063-019-3545-7].

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