HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01315353
First received: March 14, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Procedure: cervical cryotherapy
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures:
  • Cervical intraepithelial neoplasia (CIN2+) (CIN2, CIN3 or invasive cancer) by biopsy 26 weeks through 130 weeks after randomization [ Time Frame: 26-130 weeks post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of high risk (hr)-HPV by the Abbott Real Time high-risk HPV assay (aHPV) at study visits. [ Time Frame: 26-130 weeks post randomization ] [ Designated as safety issue: No ]
  • Cervical cytology results at study visits. [ Time Frame: 26-130 weeks post randomization ] [ Designated as safety issue: No ]
  • Time to CIN2+ diagnosis by biopsy, as determined by local review at a DAIDS-assessed laboratory. [ Time Frame: 26-130 weeks post randomization ] [ Designated as safety issue: No ]
  • CIN3+ (CIN3 or invasive cancer) by biopsy 26 weeks post randomization through 130 weeks post randomization, as determined by local review at a DAIDS-assessed laboratory. [ Time Frame: 26-130 weeks post randomization ] [ Designated as safety issue: No ]
  • Early study discontinuation rates and reasons. [ Time Frame: 0-130 weeks post randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: March 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Immediate cryotherapy (HPV test-and-treat)
Participants in Arm A (HPV test-and-treat) will undergo cervical cryotherapy at entry. Post entry, participants in Arm A will be seen at regular intervals for the collection of cervical specimens, cytology, and as needed cervical colposcopy, directed biopsies, and LEEP.
Procedure: cervical cryotherapy
Participants will undergo cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Participants found to have CIN2+ by biopsy at any point during the study will be offered LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Experimental: Arm B: cytology-based strategy
Participants in Arm B will follow a cytology-based management plan involving three steps- cytology, colposcopy with directed biopsies, and LEEP (as needed).
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Participants found to have CIN2+ by biopsy at any point during the study will be offered LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
Experimental: Arm C : Ineligible for randomization to Arm A or B
Participants will be eligible for Arm C under the conditions noted in the inclusion criteria. Participants in Arm C will undergo colposcopy and directed biopsies at entry. If CIN2+ is found by biopsy, then LEEP will be performed and a follow-up visit 26 weeks after these procedures will be scheduled for the collection of cervical specimens, cytology, and as needed cervical colposcopy, directed biopsies, and LEEP. After the week 26 visit, Arm C participants will go off study.
Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Participants found to have CIN2+ by biopsy at any point during the study will be offered LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infection.
  • Certain laboratory values obtained within 30 days prior to study entry (more information can be found in the protocol).
  • For candidates suitable for cervical cryotherapy, hr-HPV detected by aHPV within 30 days prior to study entry.
  • For women without hr-HPV detected by the aHPV assay, presence of lesions on visual inspection or HSIL cervical cytology. These participants are not eligible for randomization to Arms A or B and will be followed in Arm C.
  • Suitable candidate for cervical cryotherapy (as defined in the protocol). Unsuitable participants are not eligible for randomization to Arms A or B and will be followed in Arm C.
  • For participants of reproductive potential, negative pregnancy test within 48 hours prior to study entry.
  • Must agree not to participate in a conception process (e.g. active attempt to get pregnant or in vitro fertilization), or use at least one reliable contraceptive if participating in sexual activity, from time of study entry until 12 weeks after study entry.
  • If recently gave birth, must be at least 12 weeks postpartum.
  • Ability and willingness of participant or legal guardian/representative to provide written informed consent.

Exclusion Criteria:

  • Current or prior history of cervical, vaginal, or vulvar cancer.
  • Prior cervical cryotherapy, LEEP, cervical conization, or total or partial hysterectomy.
  • Cervical, vaginal, or vulvar lesions that are suspicious on clinical exam for cancer.
  • Visual evidence of bacterial STIs or suspicion of pelvic inflammatory disease.
  • Prior vaccination with an HPV vaccine.
  • Hemophilia.
  • Currently on anticoagulation therapy other than acetylsalicylic acid.
  • Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to study entry.
  • Active drug or alcohol use or dependence or any other condition that, in the opinion of the site investigator, would interfere with the participant's ability to adhere to study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315353

Locations
Botswana
Gaborone Prevention/Treatment Trials CRS (12701)
Gaborone, Botswana
Molepolole Prevention/Treatment Trials CRS (12702)
Molepolole, Botswana
Haiti
Les Centres GHESKIO CRS (30022)
Bicentenaire, Port-au-Prince, Haiti, HT-6110
India
National AIDS Research Institute Pune CRS (11601)
Pune, Maharashtra, India, 411026
BJ Medical College CRS (31441)
Pune, Maharashtra, India, 411001
Malawi
College of Med. JHU CRS (30301)
Blantyre, Malawi
University of North Carolina Lilongwe CRS (12001)
Lilongwe, Malawi
Peru
Investigaciones Medicas en Salud (INMENSA) (11302)
San Isidro, Lima, Peru
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301)
Lima, Peru, 18 PE
South Africa
Durban Adult HIV CRS (11201)
Durban, South Africa, 4013 SF
Univ. of Witwatersrand CRS (11101)
Johannesburg, South Africa
Soweto ACTG CRS (12301)
Johannesburg, South Africa
Zambia
Kalingalinga Clinic CRS (12801)
Lusaka, Zambia
Zimbabwe
UZ-Parirenyatwa CRS (30313)
Harare, Zimbabwe
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Timothy J Wilkin, MD, MPH Cornell Clinical Research Site
  More Information

No publications provided

Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01315353     History of Changes
Other Study ID Numbers: ACTG A5282, 1U01AI068636
Study First Received: March 14, 2011
Last Updated: September 3, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 23, 2014