Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519994
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Feasibility of Intravaginal Artesunate as Adjuvant HPV Cervical Precancer Treatment in Kenya
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Intravaginal Artesunate as Adjuvant HPV Cervical Precancer Treatment Among Women Living With HIV in Kenya
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this randomized placebo-controlled trial is to evaluate whether intravaginal artesunate pessaries vaginal inserts can be used as adjuvant therapy following thermal ablation to improve Human papillomavirus HPV treatment outcomes in Women Living with Human Immunodeficiency Virus WLWH
The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months compared to those who used a placebo The study will also assess the safety adherence and acceptability of this treatment 120 participants will be enrolled in the study Participants will self-administer the study drug nightly for 5 days take a week off and repeat twice use study drug on weeks 1 35 and will return to the clinic on weeks 2 4 6 12 and week 24 for follow-up
The study will evaluate whether women who use artesunate will have higher HPV clearance at 6 months compared to those who used a placebo The study will also assess the safety adherence and acceptability of this treatment 120 participants will be enrolled in the study Participants will self-administer the study drug nightly for 5 days take a week off and repeat twice use study drug on weeks 1 35 and will return to the clinic on weeks 2 4 6 12 and week 24 for follow-up
Detailed Description:
WLWH face up to six times increased risk of cervical cancer as a result cervical cancer is a leading cause of death in this population Cervical cancer is caused by persistent infection with the human papillomavirus HPV resulting in precancerous changes that if not adequately treated progress to cancer Thermal ablation is a commonly used treatment for cervical precancer in Kenya and other low- and middle-income countries LMICs Current treatments for HPV or cervical precancer including thermal ablation are associated with high rates of treatment failure in WLWH In a recent study from Zambia only 44 of WLWH had cleared HPV at six months following thermal ablation treatment Other studies have demonstrated up to 30 recurrence rate of high-grade cervical precancer at 12 to 24 months after treatment Persistent infection with HPV following precancer treatment is a key risk factor for treatment disease recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None