HIV InfectionsKingaNCT03701802
Immunogenetic Modulators of Mucosal Protection From HIV-1
An observational study of HIV Infections and HSV-2 Infection, run by University of Washington at 1 site in Kenya.
Trial summary
This is a single site, prospective, observational study that seeks to assess changes in mucosal immunity that occur as a result of HIV-1 exposure, HSV-2 infection, and/or pre-exposure prophylaxis (PrEP) usage to prevent HIV-1 acquisition. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HSV-2 Infection
- How many people
- 812 participants
- Where
- 1 siteKenya
- Study dates
- 27 Sep 2018to 30 Sep 2020
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African heterosexual HIV-serodiscordant (SDC) and HIV-1 concordant negative couples (CNC)
Who may be able to join
- HIV-1 Uninfected Participants;
- Age ≥18 and ≤65 and able to provide independent informed consent for research per local regulations and guidelines
- Able and willing to provide written informed consent to be screened for and to take part in the study
- Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants. Couples are defined by the following criteria:
- Partners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months)
- Partners plan to remain in the relationship for the duration of the study period.
Show all 16Show fewer
- HIV-1 uninfected status is based on parallel negative HIV-1 rapid tests, both at study screening and at the enrollment visit
- Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures
- HIV-1 Infected Participants;
- Of legal age to provide independent informed consent for research per local regulations and guidelines.
- Able and willing to provide written informed consent to be screened for and to take part in the study.
- Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants
- Current or previous use of antiretroviral therapy with unsuppressed HIV-1 viral load
- HIV-1 infected based on positive EIA and, when available, detectable viral load.
- No history of any clinical AIDS-defining diagnoses.
- Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.
Who cannot join
- HIV-1 Uninfected Participants;
- Abnormal serum creatinine (based on sub-Saharan African normal values)
- Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease, pulmonary disease, diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.
- Receiving ongoing therapy with any of the following at the time of enrollment: antiretroviral therapy (ART), including nucleoside analogs, nonnucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agent
- At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data)
- Pregnant at the time of screening
Show all 11Show fewer
- HIV-1 Infected Participants;
- Current or previous use of antiretroviral therapy with suppressed HIV-1 viral load
- Currently enrolled in another HIV-1 treatment trial
- At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives.
- Pregnant at the time of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenetic Modulators of Mucosal Protection From HIV-1: The Kinga Study
This is a single site, prospective, observational study that seeks to assess changes in mucosal immunity that occur as a result of HIV-1 exposure, HSV-2 infection, and/or pre-exposure prophylaxis (PrEP) usage to prevent HIV-1 acquisition. The study will collect mucosal and peripheral blood samples for a detailed analysis of longitudinal immune responses, while also obtaining samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk.
Read the detailed description
A challenge to development of HIV-1 vaccines is to better understand the natural immune mechanisms for protection from HIV-1 infection. To this end, immunologists have increasingly appreciated the importance of regulatory T cells in peripheral blood that modulate the magnitude and characteristics of the host inflammatory response including against infectious diseases. The investigators have recently identified specific host genetic variants in the genes CD101 and UBE2V1 that appear to strongly predispose to HIV-1 infection risk and may act through regulatory T cells and other immunologic pathways. Most studies of individuals who are repeatedly HIV-1 exposed but remain seronegative (HESN) have focused on immunological correlates in peripheral blood rather than mucosal immune responses. However, with genital mucosal tissues being the portal of entry for heterosexually transmitted HIV-1 infection, it is critical to understand the role of immunological responses to HIV-1 that occur in the genital mucosa. A valuable model to carry out such studies is offered by evaluation of HIV-Exposed SeroNegative (HESN) individuals, particularly in the context of heterosexual sex with a stable HIV-1 infected partner e.g., HIV-1 serodiscordant couples (SDC). In order to understand how genital exposure to HIV-1 may modulate these immune pathways, HIV-1 serodiscordant couples should be compared to heterosexual partners in concordant HIV-1 negative couples (CNC) where neither partner has HIV-1. This study seeks to address this important knowledge gap by enrolling high-risk HESN with defined heterosexual HIV-1 exposures in the context of serodiscordant partnerships compared to unexposed concordant seronegative controls. The study will prospectively collect mucosal and peripheral blood samples for a detailed analysis of longitudinal immune responses, while also obtaining samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk.
Primary Objectives:
- To identify mucosal immunoregulatory mechanisms mediating host response to heterosexual exposure to HIV-1.
- To determine how high priority variants in CD101 and UBE2V1 modify host mucosal responses in HIV-1 exposure and infection.
Secondary Objectives:
- Identify factors (including HIV-1 exposure, host genetic and microbiota) that modify immunoregulatory mechanisms mediating host response to HIV-1
- Evaluate how these immunogenetic regulatory mechanisms influence other infectious and immunological outcomes
- Evaluate the effect of PrEP on early HIV-1 disease
- Conditions
- HIV Infections, HSV-2 Infection
- Keywords
- HIV prevention, Tenofovir Disoproxil Fumarate (TDF)/Emtricitabine (FTC), PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 serodiscordant couples | Heterosexual couples in which one partner is infected with HIV-1 and the other partner is HIV-1 uninfected | |
| Concordant HIV-1 negative couples | Heterosexual couples in which both partners are HIV-1 uninfected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of genital-tract tissue resident memory (TRM) cells
We will compare frequency of CD69+ among CD8+ TRM in genital tissues between HIV-1 exposed and HIV-1 unexposed individuals
Measured: At 6 months of follow-up
Secondary outcomes (1)
Prevalence of genital-tract tissue resident memory (TRM) cells in individuals with versus without CD101 immunoglobulin-like (Ig-like) variants.
We will compare frequency of CD69+ among CD8+ TRM in genital tissues in individuals with versus without CD101 immunoglobulin-like (Ig-like) variants.
Measured: At 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start27 Sep 2018
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kenya Medical Research Institute
- Responsible party
- Principal investigator, Jairam Lingappa, University of Washington
- Investigators
- Jairam Lingappa, MD, PhD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701802
- Sponsor's protocol ID
- STUDY00001559
- Other IDs
- R01AI129715, R01AI131914, R01AI141435
- Acronym
- Kinga
- Status last verified
- Nov 2020
- First submitted
- 21 Sep 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data for all outcome measures
Publications
Pattacini L, Baeten JM, Thomas KK, Fluharty TR, Murnane PM, Donnell D, Bukusi E, Ronald A, Mugo N, Lingappa JR, Celum C, McElrath MJ, Lund JM; Partners PrEP Study Team. Regulatory T-Cell Activity But Not Conventional HIV-Specific T-Cell Responses Are Associated With Protection From HIV-1 Infection. J Acquir Immune Defic Syndr. 2016 Jun 1;72(2):119-28. doi: 10.1097/QAI.0000000000000919.
PubMed 26656786Pattacini L, Murnane PM, Baeten JM, Fluharty TR, Thomas KK, Bukusi E, Katabira E, Mugo N, Donnell D, Lingappa JR, Celum C, Marzinke M, McElrath MJ, Lund JM; Partners PrEP Study Team. Antiretroviral Pre-Exposure Prophylaxis Does Not Enhance Immune Responses to HIV in Exposed but Uninfected Persons. J Infect Dis. 2015 Jun 15;211(12):1943-52. doi: 10.1093/infdis/jiu815. Epub 2014 Dec 17.
PubMed 25520426Lund JM, Broliden K, Pyra MN, Thomas KK, Donnell D, Irungu E, Muwonge TR, Mugo N, Manohar M, Jansson M, Mackelprang R, Marzinke MA, Baeten JM, Lingappa JR. HIV-1-Neutralizing IgA Detected in Genital Secretions of Highly HIV-1-Exposed Seronegative Women on Oral Preexposure Prophylaxis. J Virol. 2016 Oct 14;90(21):9855-9861. doi: 10.1128/JVI.01482-16. Print 2016 Nov 1.
PubMed 27558421Alimonti JB, Koesters SA, Kimani J, Matu L, Wachihi C, Plummer FA, Fowke KR. CD4+ T cell responses in HIV-exposed seronegative women are qualitatively distinct from those in HIV-infected women. J Infect Dis. 2005 Jan 1;191(1):20-4. doi: 10.1086/425998. Epub 2004 Dec 1.
PubMed 15592998Biasin M, Piacentini L, Lo Caputo S, Naddeo V, Pierotti P, Borelli M, Trabattoni D, Mazzotta F, Shearer GM, Clerici M. TLR activation pathways in HIV-1-exposed seronegative individuals. J Immunol. 2010 Mar 1;184(5):2710-7. doi: 10.4049/jimmunol.0902463. Epub 2010 Feb 1.
PubMed 20124101Pattacini L, Murnane PM, Kahle EM, Bolton MJ, Delrow JJ, Lingappa JR, Katabira E, Donnell D, McElrath MJ, Baeten JM, Lund JM. Differential regulatory T cell activity in HIV type 1-exposed seronegative individuals. AIDS Res Hum Retroviruses. 2013 Oct;29(10):1321-9. doi: 10.1089/AID.2013.0075. Epub 2013 Jul 30.
PubMed 23815575Mackelprang RD, Baeten JM, Donnell D, Celum C, Farquhar C, de Bruyn G, Essex M, McElrath MJ, Nakku-Joloba E, Lingappa JR; Partners in Prevention HSV/HIV Transmission Study Team. Quantifying ongoing HIV-1 exposure in HIV-1-serodiscordant couples to identify individuals with potential host resistance to HIV-1. J Infect Dis. 2012 Oct;206(8):1299-308. doi: 10.1093/infdis/jis480. Epub 2012 Aug 27.
PubMed 22926009Wald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis. 2002 Jan 1;185(1):45-52. doi: 10.1086/338231. Epub 2001 Dec 14.
PubMed 11756980Eichhorn EJ, Tandon PK, DiBianco R, Timmis GC, Fenster PE, Shannon J, Packer M. Clinical and prognostic significance of serum magnesium concentration in patients with severe chronic congestive heart failure: the PROMISE Study. J Am Coll Cardiol. 1993 Mar 1;21(3):634-40. doi: 10.1016/0735-1097(93)90095-i.
PubMed 8436744Mackelprang RD, Bamshad MJ, Chong JX, Hou X, Buckingham KJ, Shively K, deBruyn G, Mugo NR, Mullins JI, McElrath MJ, Baeten JM, Celum C, Emond MJ, Lingappa JR; Partners in Prevention HSV/HIV Transmission Study and the Partners PrEP Study Teams. Whole genome sequencing of extreme phenotypes identifies variants in CD101 and UBE2V1 associated with increased risk of sexually acquired HIV-1. PLoS Pathog. 2017 Nov 6;13(11):e1006703. doi: 10.1371/journal.ppat.1006703. eCollection 2017 Nov.
PubMed 29108000Hughes JP, Baeten JM, Lingappa JR, Magaret AS, Wald A, de Bruyn G, Kiarie J, Inambao M, Kilembe W, Farquhar C, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Determinants of per-coital-act HIV-1 infectivity among African HIV-1-serodiscordant couples. J Infect Dis. 2012 Feb 1;205(3):358-65. doi: 10.1093/infdis/jir747. Epub 2012 Jan 11.
PubMed 22241800Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
PubMed 22784037MacLean F, Tsegaye AT, Graham JB, Swarts JL, Vick SC, Potchen NB, Cruz Talavera I, Warrier L, Dubrulle J, Schroeder LK, Saito A, Mar C, Thomas KK, Mack M, Sabo MC, Chohan BH, Ngure K, Mugo NR, Lingappa JR, Lund JM; Kinga Study Team. Bacterial vaginosis associates with dysfunctional T cells and altered soluble immune factors in the cervicovaginal tract. J Clin Invest. 2025 Mar 25;135(10):e184609. doi: 10.1172/JCI184609. eCollection 2025 May 15.
PubMed 40131862
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetic Modulators of Mucosal Protection From HIV-1: The Kinga Study
- ClinicalTrials.gov ID
- NCT03701802
- Acronym / sponsor ID
- Kinga / STUDY00001559
- Conditions
- HIV Infections, HSV-2 Infection
- Keywords
- HIV prevention, Tenofovir Disoproxil Fumarate (TDF)/Emtricitabine (FTC), PrEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kenya Medical Research Institute
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 10 Oct 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 is a single site, prospective, observational study that seeks to assess changes in mucosal immunity that occur as a result of HIV-1 exposure, HSV-2 infection, and/or pre-exposure prophylaxis (PrEP) usage to prevent HIV-1 acquisition. The study will collect mucosal and peripheral blood samples for a detailed analysis of longitudinal immune responses, while also obtaining samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk.
Detailed description
A challenge to development of HIV-1 vaccines is to better understand the natural immune mechanisms for protection from HIV-1 infection. To this end, immunologists have increasingly appreciated the importance of regulatory T cells in peripheral blood that modulate the magnitude and characteristics of the host inflammatory response including against infectious diseases. The investigators have recently identified specific host genetic variants in the genes CD101 and UBE2V1 that appear to strongly predispose to HIV-1 infection risk and may act through regulatory T cells and other immunologic pathways. Most studies of individuals who are repeatedly HIV-1 exposed but remain seronegative (HESN) have focused on immunological correlates in peripheral blood rather than mucosal immune responses. However, with genital mucosal tissues being the portal of entry for heterosexually transmitted HIV-1 infection, it is critical to understand the role of immunological responses to HIV-1 that occur in the genital mucosa. A valuable model to carry out such studies is offered by evaluation of HIV-Exposed SeroNegative (HESN) individuals, particularly in the context of heterosexual sex with a stable HIV-1 infected partner e.g., HIV-1 serodiscordant couples (SDC). In order to understand how genital exposure to HIV-1 may modulate these immune pathways, HIV-1 serodiscordant couples should be compared to heterosexual partners in concordant HIV-1 negative couples (CNC) where neither partner has HIV-1. This study seeks to address this important knowledge gap by enrolling high-risk HESN with defined heterosexual HIV-1 exposures in the context of serodiscordant partnerships compared to unexposed concordant seronegative controls. The study will prospectively collect mucosal and peripheral blood samples for a detailed analysis of longitudinal immune responses, while also obtaining samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk.
Primary Objectives:
- To identify mucosal immunoregulatory mechanisms mediating host response to heterosexual exposure to HIV-1.
- To determine how high priority variants in CD101 and UBE2V1 modify host mucosal responses in HIV-1 exposure and infection.
Secondary Objectives:
- Identify factors (including HIV-1 exposure, host genetic and microbiota) that modify immunoregulatory mechanisms mediating host response to HIV-1
- Evaluate how these immunogenetic regulatory mechanisms influence other infectious and immunological outcomes
- Evaluate the effect of PrEP on early HIV-1 disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-1 serodiscordant couples | – | –Heterosexual couples in which one partner is infected with HIV-1 and the other partner is HIV-1 uninfected |
| Concordant HIV-1 negative couples | – | –Heterosexual couples in which both partners are HIV-1 uninfected |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African heterosexual HIV-serodiscordant (SDC) and HIV-1 concordant negative couples (CNC)
Key inclusion criteria (16 listed)
- HIV-1 Uninfected Participants;
- Age ≥18 and ≤65 and able to provide independent informed consent for research per local regulations and guidelines
- Able and willing to provide written informed consent to be screened for and to take part in the study
- Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants. Couples are defined by the following criteria:
- Partners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months)
Key exclusion criteria (11 listed)
- HIV-1 Uninfected Participants;
- Abnormal serum creatinine (based on sub-Saharan African normal values)
- Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease, pulmonary disease, diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.
- Receiving ongoing therapy with any of the following at the time of enrollment: antiretroviral therapy (ART), including nucleoside analogs, nonnucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agent
- At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of genital-tract tissue resident memory (TRM) cells
Time frame: At 6 months of follow-up
We will compare frequency of CD69+ among CD8+ TRM in genital tissues between HIV-1 exposed and HIV-1 unexposed individuals
1 secondary outcome
Prevalence of genital-tract tissue resident memory (TRM) cells in individuals with versus without CD101 immunoglobulin-like (Ig-like) variants.
Time frame: At 6 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 26656786Pattacini L, Baeten JM, Thomas KK, Fluharty TR, Murnane PM, Donnell D, Bukusi E, Ronald A, Mugo N, Lingappa JR, Celum C, McElrath MJ, Lund JM; Partners PrEP Study Team. Regulatory T-Cell Activity But Not Conventional HIV-Specific T-Cell Responses Are Associated With Protection From HIV-1 Infection. J Acquir Immune Defic Syndr. 2016 Jun 1;72(2):119-28. doi: 10.1097/QAI.0000000000000919.
- Background: PubMed 25520426Pattacini L, Murnane PM, Baeten JM, Fluharty TR, Thomas KK, Bukusi E, Katabira E, Mugo N, Donnell D, Lingappa JR, Celum C, Marzinke M, McElrath MJ, Lund JM; Partners PrEP Study Team. Antiretroviral Pre-Exposure Prophylaxis Does Not Enhance Immune Responses to HIV in Exposed but Uninfected Persons. J Infect Dis. 2015 Jun 15;211(12):1943-52. doi: 10.1093/infdis/jiu815. Epub 2014 Dec 17.
- Background: PubMed 27558421Lund JM, Broliden K, Pyra MN, Thomas KK, Donnell D, Irungu E, Muwonge TR, Mugo N, Manohar M, Jansson M, Mackelprang R, Marzinke MA, Baeten JM, Lingappa JR. HIV-1-Neutralizing IgA Detected in Genital Secretions of Highly HIV-1-Exposed Seronegative Women on Oral Preexposure Prophylaxis. J Virol. 2016 Oct 14;90(21):9855-9861. doi: 10.1128/JVI.01482-16. Print 2016 Nov 1.
- Background: PubMed 15592998Alimonti JB, Koesters SA, Kimani J, Matu L, Wachihi C, Plummer FA, Fowke KR. CD4+ T cell responses in HIV-exposed seronegative women are qualitatively distinct from those in HIV-infected women. J Infect Dis. 2005 Jan 1;191(1):20-4. doi: 10.1086/425998. Epub 2004 Dec 1.
- Background: PubMed 20124101Biasin M, Piacentini L, Lo Caputo S, Naddeo V, Pierotti P, Borelli M, Trabattoni D, Mazzotta F, Shearer GM, Clerici M. TLR activation pathways in HIV-1-exposed seronegative individuals. J Immunol. 2010 Mar 1;184(5):2710-7. doi: 10.4049/jimmunol.0902463. Epub 2010 Feb 1.
- Background: PubMed 23815575Pattacini L, Murnane PM, Kahle EM, Bolton MJ, Delrow JJ, Lingappa JR, Katabira E, Donnell D, McElrath MJ, Baeten JM, Lund JM. Differential regulatory T cell activity in HIV type 1-exposed seronegative individuals. AIDS Res Hum Retroviruses. 2013 Oct;29(10):1321-9. doi: 10.1089/AID.2013.0075. Epub 2013 Jul 30.
- Background: PubMed 22926009Mackelprang RD, Baeten JM, Donnell D, Celum C, Farquhar C, de Bruyn G, Essex M, McElrath MJ, Nakku-Joloba E, Lingappa JR; Partners in Prevention HSV/HIV Transmission Study Team. Quantifying ongoing HIV-1 exposure in HIV-1-serodiscordant couples to identify individuals with potential host resistance to HIV-1. J Infect Dis. 2012 Oct;206(8):1299-308. doi: 10.1093/infdis/jis480. Epub 2012 Aug 27.
- Background: PubMed 11756980Wald A, Link K. Risk of human immunodeficiency virus infection in herpes simplex virus type 2-seropositive persons: a meta-analysis. J Infect Dis. 2002 Jan 1;185(1):45-52. doi: 10.1086/338231. Epub 2001 Dec 14.
- Background: PubMed 8436744Eichhorn EJ, Tandon PK, DiBianco R, Timmis GC, Fenster PE, Shannon J, Packer M. Clinical and prognostic significance of serum magnesium concentration in patients with severe chronic congestive heart failure: the PROMISE Study. J Am Coll Cardiol. 1993 Mar 1;21(3):634-40. doi: 10.1016/0735-1097(93)90095-i.
- Background: PubMed 29108000Mackelprang RD, Bamshad MJ, Chong JX, Hou X, Buckingham KJ, Shively K, deBruyn G, Mugo NR, Mullins JI, McElrath MJ, Baeten JM, Celum C, Emond MJ, Lingappa JR; Partners in Prevention HSV/HIV Transmission Study and the Partners PrEP Study Teams. Whole genome sequencing of extreme phenotypes identifies variants in CD101 and UBE2V1 associated with increased risk of sexually acquired HIV-1. PLoS Pathog. 2017 Nov 6;13(11):e1006703. doi: 10.1371/journal.ppat.1006703. eCollection 2017 Nov.
- Background: PubMed 22241800Hughes JP, Baeten JM, Lingappa JR, Magaret AS, Wald A, de Bruyn G, Kiarie J, Inambao M, Kilembe W, Farquhar C, Celum C; Partners in Prevention HSV/HIV Transmission Study Team. Determinants of per-coital-act HIV-1 infectivity among African HIV-1-serodiscordant couples. J Infect Dis. 2012 Feb 1;205(3):358-65. doi: 10.1093/infdis/jir747. Epub 2012 Jan 11.
- Background: PubMed 22784037Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
- Mackelprang et. al. ftPiPHHTaPP. Rare host genetic variation influencing risk of heterosexual HIV-1 acquisition. Congress on Retroviruses and Opportunistic Infections (CROI - 2016)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for all outcome measures
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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.
Jairam Lingappa, MD, PhD study chair
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HSV-2 Infection, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Nov 2020. 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 Kenya. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of genital-tract tissue resident memory (TRM) cells (time frame: At 6 months of follow-up). 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 NCT03701802, which also lists 13 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 3 Nov 2020.