CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Human Papillomavirus vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01928225
NCT01928225Phase 2Completed
CompareCT.gov

A Randomized, Placebo-controlled Trial of Pre-treatment HPV Vaccination on Outcomes to LEEP Treatment of Cervical High Grade Squamous Intraepithelial Lesions in HIV-infected Women.

University of Witwatersrand, South Africa·interventional·Posted Aug 23, 2013·Updated Jun 24, 2020

In Brief

A Phase 2 clinical trial evaluating Human Papillomavirus vaccine for Cervical High Grade Squamous Intraepithelial Lesion. Completed, enrolled 180 participants.

Detailed Summary

Cervical cancer occurs commonly in HIV-infected women in South Africa. These women have poor response to treatment of cervical cancer precursors. This study will test whether giving the quadrivalent vaccine to women prior to surgical treatment of the cervical cancer precursor will improve outcomes. We hypothesize that pre-treatment HPV vaccine will result in a reduced occurrence or cervical cancer precursors in follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical High Grade Squamous Intraepithelial Lesion
Countries--
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 23, 2013
Enrollment StartSep 2, 2014
Primary CompletionNov 30, 2017
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.9 years ago

Interventions

Human Papillomavirus vaccinebiological

The participants receive the qHPV vaccine at entry, week 4 and week 26