CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 467 enrolled
Drug / intervention
Cervical Cryotherapy +1 moreprocedure
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/NCT01315353
NCT01315353N/ACompleted

A Randomized Trial To Compare An HPV Test-And-Treat Strategy To A Cytology-Based Strategy For Prevention Of CIN 2+ In HIV-Infected Women

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Mar 15, 2011·Updated May 11, 2018

In Brief

A clinical study evaluating Cervical Cryotherapy and Loop Electrosurgical Excision Procedure (LEEP) for HIV-1 Infection. Completed, enrolled 467 participants across 13 sites in 7 countries.

Detailed Summary

Women sometimes develop cancer in an area called the cervix, which is the opening to the uterus, or womb. Women who have HIV are more likely to get this kind of cancer than women who do not have HIV. Nearly all of these cancers are caused by another virus, called human papilloma virus (or HPV). Other times, the cause of this cancer is not known. The investigators are looking for a better way to prevent cervical cancer. This study is comparing two different methods to prevent cancer of the cervix in women who have HIV. This study will also see if these methods are safe and tolerable in women who have HIV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBotswana, Haiti, India, Malawi, Peru, South Africa, Zimbabwe

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2011
Enrollment StartApr 4, 2012
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.3 years ago

Interventions

Cervical Cryotherapyprocedure

Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.

Loop Electrosurgical Excision Procedure (LEEP)procedure

Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.