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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| University of Liverpool | OTHER |
| Imperial College London | OTHER |
| MRC/UVRI Uganda Research Unit |
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To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control | No Intervention | No PrEP. | |
| Arm 2: FTC-TDF | Experimental | FTC-TDF one day, 5 hours before circumcision. |
|
| Arm 3: FTC-TDF | Experimental | FTC-TDF one day, 21 hours before circumcision. |
|
| Arm 4: FTC-TDF | Experimental | FTC-TDF two days, 5 hours before circumcision. |
|
| Arm 5: FTC-TDF | Experimental | FTC-TDF two days, 21 hours before circumcision. |
|
| Arm 6: FTC-TAF | Experimental | FTC-TAF one day, 5 hours before circumcision. |
|
| Arm 7: FTC-TAF |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir | Drug | Pre-exposure prophylaxis |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV Infection free | We will ascertain the proportion of patients' foreskin tissue that is not infected with HIV 15 days following our ex-vivo HIV challenge. We will use the concentration of p24 antigen (pg/mL) at day15 and also report the slope of the p24 curves from day 3 to 15 (pg/mL per day) and also the AUC day 3 to 15 (pg/mL days). | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Timing | The delay between the timing of last dose of FTC-TDF and FTC-TAF as oral PrEP and the timing of circumcision. | 1 year |
| Dose | The efficacy of preventing in-vitro HIV infection by dose of FTC-TDF and FTC-TAF as oral PrEP compared to no intervention |
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Inclusion Criteria:
Participants must satisfy all the following criteria within 21 days prior to their circumcision visit:
Exclusion Criteria:
Male genital anatomical features.
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| Name | Affiliation | Role |
|---|---|---|
| Neil A Martinson | Perinatal HIV Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Perinatal HIV Research Unit | Johannesburg | Gauteng | 1862 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33121503 | Derived | Nash S, Dietrich J, Ssemata AS, Herrera C, O'Hagan K, Else L, Chiodi F, Kelly C, Shattock R, Chirenje M, Lebina L, Khoo S, Bekker LG, Weiss HA, Gray C, Stranix-Chibanda L, Kaleebu P, Seeley J, Martinson N, Fox J; CHAPS team. Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa-study protocol for a mixed-methods study including a randomised controlled trial. Trials. 2020 Oct 30;21(1):900. doi: 10.1186/s13063-020-04760-x. |
| Label | URL |
|---|---|
| Related Info | View source |
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Data will be shared with callaborators.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| C442442 | tenofovir alafenamide |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| UNKNOWN |
| Karolinska Institutet | OTHER |
| King's College London | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
Open-label, randomised controlled trial (RCT)
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| Experimental |
FTC-TAF one day, 21 hours before circumcision. |
|
| Arm 8: FTC-TAF | Experimental | FTC-TAF two days, 5 hours before circumcision. |
|
| Arm 9: FTC-TAF | Experimental | FTC-TAF two days, 21 hours before circumcision. |
|
|
| 1 year |
| Blood PrEP Concentrations | Plasma concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection. | 1 year |
| Rectal Fluid PrEP concentrations | Rectal fluid concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection. | 1 year |
| Foreskin tissue PrEP concentration | Foreskin tissue concentrations (ng/mL) of FTC, TFV, TAF and their active metabolites that are required for ex vivo HIV protection | 1 year |
| Efficacy of post-exposure PrEP | The proportion of participants' foreskin tissue that remains HIV infection free in the ex-vivo challenge model when additional doses of PrEP are added to that model. | 1 year |
| Related Info | View source |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |