Foreskin HIV SusceptibilityNCT03412071
Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men
A study testing Oral Tinidazole, Topical metronidazole and Topical Clindamycin in people with Foreskin HIV Susceptibility, run by University of Toronto at 1 site in Uganda.
Trial summary
This pilot study will assess the impact of four antimicrobial products (3 topical, one systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells. Participants will include HIV-uninfected Ugandan men presenting for elective male circumcision to reduce their HIV risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foreskin HIV Susceptibility
- What is being tested?
- Oral Tinidazole, Topical metronidazole and Topical Clindamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUganda
- Study dates
- 7 Dec 2017to 7 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Enrollment criteria include:
- Aged 18 years or older
- Biological male
- Uncircumcised
- HIV seronegative
- Willing to comply with the requirements of the protocol
- No current sexually transmitted infection (N. gonorrhoeae or C. trachomatis)
- No clinically relevant genital symptoms / signs
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
UVRI-IAVI HIV Vaccine Program
Entebbe, Wakiso
Bernard S Bagaya, PhD, +256787082820, bbagaya@iavi.or.ug
About this study
Official title: Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men
This pilot study will assess the impact of four antimicrobial products (3 topical, one systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells. Participants will include HIV-uninfected Ugandan men presenting for elective male circumcision to reduce their HIV risk.
Read the detailed description
RATIONALE: The foreskin is the site of most HIV acquisition in uncircumcised heterosexual men, and male circumcision (MC) reduces HIV risk by almost 60%. However, cultural and practical barriers have led to suboptimal uptake. Foreskin inflammation, defined by elevated levels of pro-inflammatory cytokines in the prepuce, is a key determinant of HIV acquisition risk in uncircumcised men, and anaerobic bacteria within the foreskin microbiome may be an important cause of this inflammation.
OBJECTIVES: A pilot in vivo - in vitro clinical study of four potential interventions to reduce HIV susceptibility in the foreskin by altering the microbiome. The study is a collaboration between the University of Toronto, IAVI-UVRI, and the Entebbe General Hospital. We will recruit 125 men presenting for elective MC, along with regular female sexual partners (if applicable). Participants will be randomized (n=25 per group) to immediate MC, or to one of four intervention arms: twice-daily application of topical metronidazole 0.75%; twice-daily application of topical clindamycin 2%; twice daily application of hydrogen peroxide 1%; or oral tinidazole 2g once a day for two days. Swabs for immune and microbiome studies will be collected before and after product. After 4 weeks the MC procedure will be performed; foreskin CD4+ T cell susceptibility to HIV will be quantified using a flow cytometry-based pseudovirus assay, and tissue immunohistochemistry performed. The primary and secondary endpoints are outlined below. A secondary study will assess the impact of penile topical antibiotic application on immunology and the microbiome in the genital tract of female sexual partners.
OUTCOMES: This in vivo - in vitro clinical trial will define the causal role of the penile microbiome in HIV susceptibility, and will assess potential strategies to take forward into HIV efficacy trials in uncircumcised heterosexual men.
- Conditions
- Foreskin HIV Susceptibility
- Being tested
- Oral Tinidazole, Topical metronidazole, Topical Clindamycin, Topical Hydrogen Peroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral TinidazoleDrug
Also called FASIGYN 500mgs
Please see description under arms
Topical metronidazoleDrug
Also called Rozex 0.75%
Please see description under arms
Topical ClindamycinDrug
Also called Dalacin cream 2%
Please see description under arms
Topical Hydrogen PeroxideDrug
Also called Crystacide 1%
Please see description under arms
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 25 HIV-uninfected, uncircumcised men will be immediately circumcised following enrollment. This group will serve as the comparison to the four intervention groups. |
| Oral tinidazole group | Active comparator | 25 HIV-uninfected, uncircumcised men will be randomized to receive oral tinidazole 2g once a day for two days. Receives: Drug: Oral Tinidazole |
| Topical metronidazole (0.75%) group | Active comparator | 25 HIV-uninfected, uncircumcised men will be randomized to apply topical 0.75% metronidazole cream to the foreskin twice a day for one week, and then twice a week for three weeks. Receives: Drug: Topical metronidazole |
| Topical clindamycin (2%) group | Active comparator | 25 HIV-uninfected, uncircumcised men will be randomized to apply topical 2% clindamycin cream to the foreskin twice a day for one week, and then twice a week for three weeks. Receives: Drug: Topical Clindamycin |
| Topical hydrogen peroxide (1%) group | Active comparator | 25 HIV-uninfected, uncircumcised men will be randomized to apply 1% hydrogen peroxide cream to the foreskin twice a day for one week, and then twice a week for three weeks. Receives: Drug: Topical Hydrogen Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
% HIV entry into foreskin derived CD4+ T cells
This measure will utilize a validated pseudovirus entry assay.
Measured: 4 weeks
Secondary outcomes (6)
Tissue density of HIV-susceptible CD4+ T cells
The density of CD4+ T cells in foreskin tissues will be assayed using immunohistochemistry, and the % pseudovirus entry (see primary endpoint, above) will be used to calculate the tissue density of HIV-susceptible CD4+ T cells.
Measured: 4 weeks
CD4+ T cell subsets in foreskin tissue
Immunofluorescence microscopy (IF) will be used to quantify CD4+ T cell subsets foreskin tissue after circumcision.
Measured: 4 weeks
Density of Langerhans cells in foreskin tissue
Immunofluorescence microscopy (IF) will be used to quantify Langerhans cells in foreskin tissue after circumcision.
Measured: 4 weeks
Presence of foreskin inflammation
Cytokine/chemokines will be assayed by ELISA, and foreskin inflammation defined as the presence of ≥3/7 inflammatory cytokines within the top quartile for that cytokine.
Measured: 4 weeks
Foreskin microbiome composition
The foreskin (prepuce) microbiome will be characterized based on 16S rRNA sequencing.
Measured: 4 weeks
Foreskin tissue explant HIV susceptibility
Foreskin tissue susecptibility to HIV infection will be quantified, based on p24 ELISA after ex vivo incubation with a primary HIV isolate.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start7 Dec 2017
- Primary completion7 Dec 2019 (estimated)
- Study completion7 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Foreskin HIV SusceptibilityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open label with 5 arms
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- UVRI-IAVI HIV Vaccine Program, Entebbe General Hospital
- Responsible party
- Principal investigator, Rupert Kaul, University of Toronto
- Investigators
- Rupert Kaul, MD/PhD, Principal investigator, University of TorontoRonald M Galiwango, MBChB/MSc, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412071
- Sponsor's protocol ID
- Penile microbiome antibiotics
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gray RH, Wawer MJ, Kigozi G. Programme science research on medical male circumcision scale-up in sub-Saharan Africa. Sex Transm Infect. 2013 Aug;89(5):345-9. doi: 10.1136/sextrans-2012-050595. Epub 2013 May 22.
PubMed 23698513Liu CM, Hungate BA, Tobian AA, Serwadda D, Ravel J, Lester R, Kigozi G, Aziz M, Galiwango RM, Nalugoda F, Contente-Cuomo TL, Wawer MJ, Keim P, Gray RH, Price LB. Male circumcision significantly reduces prevalence and load of genital anaerobic bacteria. mBio. 2013 Apr 16;4(2):e00076. doi: 10.1128/mBio.00076-13.
PubMed 23592260Prodger JL, Gray R, Kigozi G, Nalugoda F, Galiwango R, Hirbod T, Wawer M, Hofer SO, Sewankambo N, Serwadda D, Kaul R. Foreskin T-cell subsets differ substantially from blood with respect to HIV co-receptor expression, inflammatory profile, and memory status. Mucosal Immunol. 2012 Mar;5(2):121-8. doi: 10.1038/mi.2011.56. Epub 2011 Nov 16.
PubMed 22089029Prodger JL, Gray RH, Shannon B, Shahabi K, Kong X, Grabowski K, Kigozi G, Nalugoda F, Serwadda D, Wawer MJ, Reynolds SJ, Liu CM, Tobian AA, Kaul R. Chemokine Levels in the Penile Coronal Sulcus Correlate with HIV-1 Acquisition and Are Reduced by Male Circumcision in Rakai, Uganda. PLoS Pathog. 2016 Nov 29;12(11):e1006025. doi: 10.1371/journal.ppat.1006025. eCollection 2016 Nov.
PubMed 27898732Prodger JL, Hirbod T, Kigozi G, Nalugoda F, Reynolds SJ, Galiwango R, Shahabi K, Serwadda D, Wawer MJ, Gray RH, Kaul R; Rakai Genital Immunology Research Group. Immune correlates of HIV exposure without infection in foreskins of men from Rakai, Uganda. Mucosal Immunol. 2014 May;7(3):634-44. doi: 10.1038/mi.2013.83. Epub 2013 Oct 23.
PubMed 24150258Menard JP. Antibacterial treatment of bacterial vaginosis: current and emerging therapies. Int J Womens Health. 2011;3:295-305. doi: 10.2147/IJWH.S23814. Epub 2011 Aug 23.
PubMed 21976983Rashed HT. Evaluation of the effect of hydrogen peroxide as a mouthwash in comparison with chlorhexidine in chronic periodontitis patients: A clinical study. J Int Soc Prev Community Dent. 2016 May-Jun;6(3):206-12. doi: 10.4103/2231-0762.183114. Epub 2016 May 30.
PubMed 27382535Armstrong NR, Wilson JD. Tinidazole in the treatment of bacterial vaginosis. Int J Womens Health. 2010 Aug 9;1:59-65. doi: 10.2147/ijwh.s4455.
PubMed 21072275Baggaley R, Doherty M, Ball A, Ford N, Hirnschall G. The Strategic Use of Antiretrovirals to Prevent HIV Infection: A Converging Agenda. Clin Infect Dis. 2015 Jun 1;60 Suppl 3:S159-60. doi: 10.1093/cid/civ091.
PubMed 25972496TenoRes Study Group. Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study. Lancet Infect Dis. 2016 May;16(5):565-575. doi: 10.1016/S1473-3099(15)00536-8. Epub 2016 Jan 29.
PubMed 26831472Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
PubMed 16231970Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
PubMed 17321310Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
PubMed 17321311Sgaier SK, Reed JB, Thomas A, Njeuhmeli E. Achieving the HIV prevention impact of voluntary medical male circumcision: lessons and challenges for managing programs. PLoS Med. 2014 May 6;11(5):e1001641. doi: 10.1371/journal.pmed.1001641. eCollection 2014 May.
PubMed 24800840Kigozi G, Wawer M, Ssettuba A, Kagaayi J, Nalugoda F, Watya S, Mangen FW, Kiwanuka N, Bacon MC, Lutalo T, Serwadda D, Gray RH. Foreskin surface area and HIV acquisition in Rakai, Uganda (size matters). AIDS. 2009 Oct 23;23(16):2209-13. doi: 10.1097/QAD.0b013e328330eda8.
PubMed 19770623
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Ability of a Microbiome - Focused Intervention to Reduce HIV Susceptibility in Ugandan Men
- ClinicalTrials.gov ID
- NCT03412071
- Acronym / sponsor ID
- Penile microbiome antibiotics
- Conditions
- Foreskin HIV Susceptibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- UVRI-IAVI HIV Vaccine Program, Entebbe General Hospital
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 7 Dec 2019 (estimated)
- Study completion
- 7 Dec 2019 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will assess the impact of four antimicrobial products (3 topical, one systemic) on the foreskin microbiome and HIV susceptibility of foreskin-derived CD4+ T cells. Participants will include HIV-uninfected Ugandan men presenting for elective male circumcision to reduce their HIV risk.
Detailed description
RATIONALE: The foreskin is the site of most HIV acquisition in uncircumcised heterosexual men, and male circumcision (MC) reduces HIV risk by almost 60%. However, cultural and practical barriers have led to suboptimal uptake. Foreskin inflammation, defined by elevated levels of pro-inflammatory cytokines in the prepuce, is a key determinant of HIV acquisition risk in uncircumcised men, and anaerobic bacteria within the foreskin microbiome may be an important cause of this inflammation.
OBJECTIVES: A pilot in vivo - in vitro clinical study of four potential interventions to reduce HIV susceptibility in the foreskin by altering the microbiome. The study is a collaboration between the University of Toronto, IAVI-UVRI, and the Entebbe General Hospital. We will recruit 125 men presenting for elective MC, along with regular female sexual partners (if applicable). Participants will be randomized (n=25 per group) to immediate MC, or to one of four intervention arms: twice-daily application of topical metronidazole 0.75%; twice-daily application of topical clindamycin 2%; twice daily application of hydrogen peroxide 1%; or oral tinidazole 2g once a day for two days. Swabs for immune and microbiome studies will be collected before and after product. After 4 weeks the MC procedure will be performed; foreskin CD4+ T cell susceptibility to HIV will be quantified using a flow cytometry-based pseudovirus assay, and tissue immunohistochemistry performed. The primary and secondary endpoints are outlined below. A secondary study will assess the impact of penile topical antibiotic application on immunology and the microbiome in the genital tract of female sexual partners.
OUTCOMES: This in vivo - in vitro clinical trial will define the causal role of the penile microbiome in HIV susceptibility, and will assess potential strategies to take forward into HIV efficacy trials in uncircumcised heterosexual men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Randomized, open label with 5 arms
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –25 HIV-uninfected, uncircumcised men will be immediately circumcised following enrollment. This group will serve as the comparison to the four intervention groups. |
| Oral tinidazole group | Active comparator | Drug: Oral Tinidazole25 HIV-uninfected, uncircumcised men will be randomized to receive oral tinidazole 2g once a day for two days. |
| Topical metronidazole (0.75%) group | Active comparator | Drug: Topical metronidazole25 HIV-uninfected, uncircumcised men will be randomized to apply topical 0.75% metronidazole cream to the foreskin twice a day for one week, and then twice a week for three weeks. |
| Topical clindamycin (2%) group | Active comparator | Drug: Topical Clindamycin25 HIV-uninfected, uncircumcised men will be randomized to apply topical 2% clindamycin cream to the foreskin twice a day for one week, and then twice a week for three weeks. |
| Topical hydrogen peroxide (1%) group | Active comparator | Drug: Topical Hydrogen Peroxide25 HIV-uninfected, uncircumcised men will be randomized to apply 1% hydrogen peroxide cream to the foreskin twice a day for one week, and then twice a week for three weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral TinidazoleAlso: FASIGYN 500mgsPlease see description under arms | Drug | Oral tinidazole group |
| Topical metronidazoleAlso: Rozex 0.75%Please see description under arms | Drug | Topical metronidazole (0.75%) group |
| Topical ClindamycinAlso: Dalacin cream 2%Please see description under arms | Drug | Topical clindamycin (2%) group |
| Topical Hydrogen PeroxideAlso: Crystacide 1%Please see description under arms | Drug | Topical hydrogen peroxide (1%) group |
Primary outcome
% HIV entry into foreskin derived CD4+ T cells
Time frame: 4 weeks
This measure will utilize a validated pseudovirus entry assay.
6 secondary outcomes
Tissue density of HIV-susceptible CD4+ T cells
Time frame: 4 weeks
CD4+ T cell subsets in foreskin tissue
Time frame: 4 weeks
Density of Langerhans cells in foreskin tissue
Time frame: 4 weeks
Presence of foreskin inflammation
Time frame: 4 weeks
Foreskin microbiome composition
Time frame: 4 weeks
Foreskin tissue explant HIV susceptibility
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Background: PubMed 23698513Gray RH, Wawer MJ, Kigozi G. Programme science research on medical male circumcision scale-up in sub-Saharan Africa. Sex Transm Infect. 2013 Aug;89(5):345-9. doi: 10.1136/sextrans-2012-050595. Epub 2013 May 22.
- Background: PubMed 23592260Liu CM, Hungate BA, Tobian AA, Serwadda D, Ravel J, Lester R, Kigozi G, Aziz M, Galiwango RM, Nalugoda F, Contente-Cuomo TL, Wawer MJ, Keim P, Gray RH, Price LB. Male circumcision significantly reduces prevalence and load of genital anaerobic bacteria. mBio. 2013 Apr 16;4(2):e00076. doi: 10.1128/mBio.00076-13.
- Background: PubMed 22089029Prodger JL, Gray R, Kigozi G, Nalugoda F, Galiwango R, Hirbod T, Wawer M, Hofer SO, Sewankambo N, Serwadda D, Kaul R. Foreskin T-cell subsets differ substantially from blood with respect to HIV co-receptor expression, inflammatory profile, and memory status. Mucosal Immunol. 2012 Mar;5(2):121-8. doi: 10.1038/mi.2011.56. Epub 2011 Nov 16.
- Background: PubMed 27898732Prodger JL, Gray RH, Shannon B, Shahabi K, Kong X, Grabowski K, Kigozi G, Nalugoda F, Serwadda D, Wawer MJ, Reynolds SJ, Liu CM, Tobian AA, Kaul R. Chemokine Levels in the Penile Coronal Sulcus Correlate with HIV-1 Acquisition and Are Reduced by Male Circumcision in Rakai, Uganda. PLoS Pathog. 2016 Nov 29;12(11):e1006025. doi: 10.1371/journal.ppat.1006025. eCollection 2016 Nov.
- Background: PubMed 24150258Prodger JL, Hirbod T, Kigozi G, Nalugoda F, Reynolds SJ, Galiwango R, Shahabi K, Serwadda D, Wawer MJ, Gray RH, Kaul R; Rakai Genital Immunology Research Group. Immune correlates of HIV exposure without infection in foreskins of men from Rakai, Uganda. Mucosal Immunol. 2014 May;7(3):634-44. doi: 10.1038/mi.2013.83. Epub 2013 Oct 23.
- Background: PubMed 21976983Menard JP. Antibacterial treatment of bacterial vaginosis: current and emerging therapies. Int J Womens Health. 2011;3:295-305. doi: 10.2147/IJWH.S23814. Epub 2011 Aug 23.
- Background: PubMed 27382535Rashed HT. Evaluation of the effect of hydrogen peroxide as a mouthwash in comparison with chlorhexidine in chronic periodontitis patients: A clinical study. J Int Soc Prev Community Dent. 2016 May-Jun;6(3):206-12. doi: 10.4103/2231-0762.183114. Epub 2016 May 30.
- Background: PubMed 21072275Armstrong NR, Wilson JD. Tinidazole in the treatment of bacterial vaginosis. Int J Womens Health. 2010 Aug 9;1:59-65. doi: 10.2147/ijwh.s4455.
- Background: PubMed 25972496Baggaley R, Doherty M, Ball A, Ford N, Hirnschall G. The Strategic Use of Antiretrovirals to Prevent HIV Infection: A Converging Agenda. Clin Infect Dis. 2015 Jun 1;60 Suppl 3:S159-60. doi: 10.1093/cid/civ091.
- Background: PubMed 26831472TenoRes Study Group. Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study. Lancet Infect Dis. 2016 May;16(5):565-575. doi: 10.1016/S1473-3099(15)00536-8. Epub 2016 Jan 29.
- Background: PubMed 16231970Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. doi: 10.1371/journal.pmed.0020298. Epub 2005 Oct 25.
- Background: PubMed 17321310Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007 Feb 24;369(9562):643-56. doi: 10.1016/S0140-6736(07)60312-2.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Kaul, MD/PhD principal investigator
University of Toronto
Ronald M Galiwango, MBChB/MSc study director
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Tinidazole, Topical metronidazole and Topical Clindamycin in people with Foreskin HIV Susceptibility, run by University of Toronto at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rupert Kaul, MD/PhD ((416) 946-7054, rupert.kaul@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% HIV entry into foreskin derived CD4+ T cells (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412071, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.