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Trial record 8 of 17 for:    IL-7 AND HIV

The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis (HCBV)

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ClinicalTrials.gov Identifier: NCT02905890
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Imperial College London
University of Liverpool
MRC/UVRI Uganda Research Unit on Aids
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:
The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal inflammation.

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis HIV Drug: Norethisterone enantate Device: Condoms Phase 4

Detailed Description:

Bacterial vaginosis (BV) is highly prevalent among women in Africa and is associated with HIV acquisition. BV has been described as a dysbiosis, or a microbial imbalance, and is treated with metronidazole; however, once treated, it often recurs rapidly. Developing robust treatment strategies to prevent recurrent BV is important for HIV prevention in key populations at high risk for HIV infection.

There is evidence that hormonal contraceptives, including depot medroxyprogesterone acetate (DMPA), decrease BV recurrence; however, there is also evidence that DMPA increases the risk of HIV infection. Encouraging women to start or switch to an alternative progestin injectable such as norethisterone enantate (NET-EN) may mitigate HIV risk whilst decreasing the risk of recurrent BV. To date, there are no published studies that have investigated the effect of NET-EN on vaginal microbiota.

The proposed study will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high risk for HIV in the Good Health for Women Project in Kampala, Uganda. Consenting and eligible women will be treated for BV, and randomised to either NET-EN plus condoms or condoms only. Women currently using DMPA will be enrolled as an observational comparison arm. All participants will be interviewed and examined; samples for vaginal microbiota, sexually transmitted infections, and inflammatory markers will be obtained. Women will be followed up after 1 week, and 1, 2, 3, 4 and 6 months. The primary outcomes will be differences in vaginal microbiota clusters, time to recurrent BV, and inflammatory markers. Qualitative research will be carried out to assess the acceptability of, and adherence to, NET-EN.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hormonal Contraception and Bacterial Vaginosis (HCBV): The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Among Women at High Risk for HIV Infection in Kampala, Uganda
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Norethisterone enanthate plus condoms
200 mg Norethisterone enanthate intramuscularly every eight weeks at enrolment, 2 and 4 months. Counseling and condoms will be provided at enrolment, 1, 2, 3 and 4 months.
Drug: Norethisterone enantate
Noristerat® 200mg, solution for intramuscular injection given every 8 weeks
Other Name: Noristerat

Device: Condoms
Latex male condoms

Active Comparator: Condoms only
Counseling and condoms will be provided at enrolment, 1, 2, 3 and 4 months.
Device: Condoms
Latex male condoms




Primary Outcome Measures :
  1. Time to diagnosis of recurrent BV [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportional of participants with Lactobacillus-dominant cluster [ Time Frame: 6 months ]
  2. Concentration of markers for inflammation [ Time Frame: 6 months ]
    Twenty-four soluble immune proteins will be quantified by in-house multiplex bead immunoassay including interleukin(IL)-1α, IL1β, IL-2, IL4, IL-6, IL-7, IL- 8, IL-12, IL-15, IL16, IFN-g, MIP-1β, SDF1β, TNF-α, IP-10, RANTES, GM-CSF, G-CSF, MIG, IFN- -β, TGF-β, MCP-1, MCP-2, MIP-3α and other immune proteins as appropriate.

  3. Acceptability of norethisterone enanthate as measured by qualitative interviews [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BV positive by Nugent score
  • HIV negative
  • Capable of providing written informed consent

Exclusion Criteria:

  • Currently pregnant or using a reliable contraception (e.g. injectables, intrauterine devices, implant, oral contraceptive pills)
  • Desiring pregnancy in the next year
  • History of tubal ligation or hysterectomy
  • Contraindication to progestin-only contraceptives
  • Unable to comprehend consent material because of language barrier or psychological difficulty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905890


Contacts
Contact: Suzanna C Francis, MSc MPH PHD +44 0207 927 2245 suzanna.francis@lshtm.ac.uk
Contact: Sarah Harman +44 0207 927 2483 Sarah.Harman@lshtm.ac.uk

Locations
Uganda
MRC/UVRI Mengo Clinic and Research Station Recruiting
Kampala, Uganda
Contact: Janet Seeley, PhD       Janet.Seeley@lshtm.ac.uk   
Contact: Yunia Mayanja, MD       Yunia.Mayanja@mrcuganda.org   
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Imperial College London
University of Liverpool
MRC/UVRI Uganda Research Unit on Aids
Investigators
Principal Investigator: Suzanna C Francis, MSc MPH PHD London School of Hygiene and Tropical Medicine

Publications:

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02905890     History of Changes
Other Study ID Numbers: QA906
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised data from consenting participants will be made available to third parties in line with Open Access data requirements after a period of exclusive use by the study investigators

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Norethindrone
Norethindrone acetate
Norethindrone enanthate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs