Clinical Trials Logo

Clinical Trial Summary

This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.


Clinical Trial Description

Women are at increased risk of HIV acquisition compared with men. A number of biological factors are associated with increased risk, many of which likely enhance risk by increasing inflammation in the female genital tract. Susceptibility to infections and immune responses in the female genital tract are regulated by hormones: progesterone increases inflammation and HIV susceptibility and estrogen decreases inflammation and enhances colonization with Lactobacilli. A Lactobacillus dominant vaginal microbiome is associated with increased protection against HIV, while a polymicrobial vaginal flora, as seen in bacterial vaginosis, is associated with increased risk. About 40% of ACB women have a polymicrobial flora. The goal of this study is to establish a Lactobacillus dominant vaginal microbiome in ACB women, that will be associated with decreased inflammation and decreased susceptibility to HIV, by administering a low level of intravaginal estrogen to increase colonization with Lactobacilli together with a Lactobacillus-containing probiotic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03837015
Study type Interventional
Source McMaster University
Contact
Status Completed
Phase Phase 1
Start date November 4, 2019
Completion date December 14, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03940521 - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed NCT03227731 - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women Phase 2/Phase 3
Completed NCT03570918 - MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy Phase 1
Active, not recruiting NCT04022967 - ANRS 12372 MODERATO Study Phase 3
Not yet recruiting NCT06282783 - Studying Topiramate for Re-Activating the HIV-1 Reservoir Phase 1/Phase 2
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting NCT03536234 - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients Phase 2
Completed NCT04340388 - Contribution of Dolutegravir to Obesity and Cardiovascular Disease Phase 4
Not yet recruiting NCT05769569 - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission Phase 1
Enrolling by invitation NCT05584397 - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Active, not recruiting NCT04388904 - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) Phase 4
Not yet recruiting NCT04894357 - Impact of V106I on Resistance to Doravirine
Completed NCT04963712 - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Phase 1
Not yet recruiting NCT04513496 - Telemedicine in HIV Care in Buenos Aires
Not yet recruiting NCT04311944 - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD N/A
Completed NCT04568239 - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Not yet recruiting NCT04311957 - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults Phase 4
Completed NCT03998176 - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE Phase 4
Completed NCT04416906 - A Test and Treat Strategy in New HIV Diagnosis. Phase 3
Completed NCT04094870 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women Phase 4