Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

Human Immunodeficiency Virus Clinical Trial

Official title:

A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858037
• Other study ID #: MTN-025
• Status: Completed
• Phase: Phase 3
• Start date: July 18, 2016
• Est. completion date: October 10, 2018

Study information

• Verified date: October 2022
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HIV Open-label Prevention Extension (HOPE).

Description:

A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1456
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Women must meet all of the following criteria to be eligible for inclusion in the study

1. Previously enrolled in MTN-020 (ASPIRE)

2. Able and willing to provide written informed consent to be screened for and to take part in the study

3. Able and willing to provide adequate locator information, as defined in site SOPs

4. HIV-uninfected based on testing performed by study staff at Screening and Enrollment

5. Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs)

6. At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation

Exclusion Criteria:

Women who meet any of the following criteria will be excluded from the study

1. Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial

2. Per participant report at Screening:

1. Plans to relocate away from the study site during study participation

2. Plans to travel away from the study site for more than three consecutive months during study participation

3. Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)

4. With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment

5. Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period

6. Currently breastfeeding

7. Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines

8. At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies

9. Has any of the following laboratory abnormalities at Screening Visit:

1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3*

2. Creatinine > Grade 3*

3. Hemoglobin > Grade 3*

4. Platelet count > Grade 3*

5. Pap result = Grade 3 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)

10. Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

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Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

Combination Product:
• Dapivirine Vaginal Ring
Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.

Locations

Country	Name	City	State
Malawi	Johns Hopkins University Research Project	Blantyre
Malawi	Malawi Clinical Research Center	Lilongwe
South Africa	Emavundleni Research Centre	Cape Town	Western Cape
South Africa	Botha's Hill Clinical Research Center	Durban	Kwa-Zulu Natal
South Africa	Chatsworth Clinical Research Center	Durban	Kwa-Zulu Natal
South Africa	eThekwini Clinical Research Center	Durban
South Africa	Isipingo Clinical Research Center	Durban	KwaZulu-Natal
South Africa	Tongaat Clinical Research Center	Durban	KwaZulu-Natal
South Africa	Verulam Clinical Research Center	Durban	KwaZulu-Natal
South Africa	Wits Reproductive Health and HIV Institute Research Centre	Johannesburg
South Africa	WRHI Clinical Research Center	Johannesburg	Gauteng
South Africa	Medical Research Council of South Africa	Westville	Durban
Uganda	Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center	Kampala
Uganda	MU-JHU Research Collaboration	Kampala
Zimbabwe	Seke South Clinical Research Center	Harare
Zimbabwe	Spilhaus Clinical Research Center	Harare
Zimbabwe	Zengeza Clinical Research Center	Harare

Sponsors (1)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.

Countries where clinical trial is conducted

Malawi,  South Africa,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women	Number of participants Grade 2, Grade 3, and all serious Adverse Events.	13 months
Primary	Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women	By measuring the residual levels of dapivirine in returned used vaginal rings.	13 months
Secondary	Incidence of HIV-1 Infection	HIV-1 infection as measured by the protocol algorithm	13 months
Secondary	Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.	HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants	13 months