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NCT02354534 · OUTCOME

Viral Clearance of HPV

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) · Source last updated 2021-04-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
41 weeks

What was measured

Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.

Analysis population: Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome.

Groups in this outcome

50 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories, 1 Cycle

Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories,2 Cycles

Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

200 mg Artesunate Suppositories,3 Cycles

Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
50 mg Artesunate Suppositories, 1 Cycle3
200 mg Artesunate Suppositories, 1 Cycle9
200 mg Artesunate Suppositories,2 Cycles8
200 mg Artesunate Suppositories,3 Cycles8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
50 mg Artesunate Suppositories, 1 Cycle1Not reportedNot reportedNot reportedNot reported
200 mg Artesunate Suppositories, 1 Cycle3Not reportedNot reportedNot reportedNot reported
200 mg Artesunate Suppositories,2 Cycles4Not reportedNot reportedNot reportedNot reported
200 mg Artesunate Suppositories,3 Cycles1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      8
    units
    Participants
description
Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.
groups
  1. description
    Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    id
    OG000
    title
    50 mg Artesunate Suppositories, 1 Cycle
  2. description
    Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    id
    OG001
    title
    200 mg Artesunate Suppositories, 1 Cycle
  3. description
    Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    id
    OG002
    title
    200 mg Artesunate Suppositories,2 Cycles
  4. description
    Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
    id
    OG003
    title
    200 mg Artesunate Suppositories,3 Cycles
param Type
COUNT_OF_PARTICIPANTS
population Description
Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome.
reporting Status
POSTED
time Frame
41 weeks
title
Viral Clearance of HPV
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice