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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AIDS Clinical Trials Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01315353
First received: March 14, 2011
Last updated: June 5, 2014
Last verified: June 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) Recruiting
Gaborone, Botswana
Contact: Tebogo Kakhu    (011 267) 393-1146    tkakhu@bhp.org.bw   
Principal Investigator: Anthony Ogwu, MBBS         
Molepolole Prevention/Treatment Trials CRS (12702) Recruiting
Molepolole, Botswana
Contact: Evans Moko, MB, ChB, MPH    011-267-592-1013    emoko@bhp.org.bw   
Principal Investigator: Aida Asmelash, MD, MPH         
Haiti
Les Centres GHESKIO CRS (30022) Recruiting
Bicentenaire, Port-au-Prince, Haiti, HT-6110
Contact: Patrice Severe, MD    509-2222241    patsevere@gheskio.org   
Principal Investigator: Jean W Pape, MD         
India
BJ Medical College CRS (31441) Recruiting
Pune, Maharashtra, India, 411001
Contact: Nishi Suryavanshi, PhD    011912026052419    nishisuryavanshi@hotmail.com   
Principal Investigator: Vidya Mave, MD, TM, MPH         
National AIDS Research Institute Pune CRS (11601) Recruiting
Pune, Maharashtra, India, 411026
Contact: Sampada Dhayarkar, MBBS    91-20-27121280    sdhayarkar@gmail.com   
Principal Investigator: Srikanth P. Tripathy, MD, MBBS         
Malawi
College of Med. JHU CRS (30301) Recruiting
Blantyre, Malawi
Contact: Leslie H. Degnan, M.P.H.    265-888-208609    ldegnan@jhu.medcol.mw   
Principal Investigator: Newton Kumwenda, MPH, PhD         
University of North Carolina Lilongwe CRS (12001) Recruiting
Lilongwe, Malawi
Contact: Mina Hosseinipour, MD    265-1 758 938    mina_hosseinipour@med.unc.edu   
Principal Investigator: Francis Martinson, MPH, PhD, MBChB         
Peru
Investigaciones Medicas en Salud (INMENSA) (11302) Recruiting
San Isidro, Lima, Peru
Contact: Fanny Garcia, R.N.    011-51-1-5621600 ext 103    fgarcia@impactaperu.org   
Principal Investigator: Aldo Lucchetti, M.D.         
Asociacion Civil Impacta Salud y Educacion - Miraf CRS (11301) Recruiting
Lima, Peru, 18 PE
Contact: Juan V. Guanira, MD, MPH    51-124-23072    jguanira@impactaperu.org   
Principal Investigator: Jorge Sanchez, MD, MPH         
South Africa
Durban Adult HIV CRS (11201) Recruiting
Durban, South Africa, 4013 SF
Contact: Fawzia Williamson    27 31 260 4365    amodf1@nu.ac.za   
Principal Investigator: Umesh Gangaram Lalloo, MD, FRCP         
Soweto ACTG CRS (12301) Recruiting
Johannesburg, South Africa
Contact: Reinet Lourens, BScN    (271) 198-99709    lourensr@phru.co.za   
Principal Investigator: Lerato Mohapi, MD         
Univ. of Witwatersrand CRS (11101) Recruiting
Johannesburg, South Africa
Contact: Pauline C Vunandlala, BS    27 11 717 2810    idsyndicate@witshealth.co.za   
Principal Investigator: Ian M Sanne, MD, FCP         
Zambia
Kalingalinga Clinic CRS (12801) Recruiting
Lusaka, Zambia
Contact: Manze Chinyama, RN       manze.chinyama@cidrz.org   
Principal Investigator: Elizabeth Stringer, M.D.         
Zimbabwe
UZ-Parirenyatwa CRS (30313) Recruiting
Harare, Zimbabwe
Contact: Jimijika Batani, B.A.    263-912272818    jbatani@uz-ucsf.co.zw   
Principal Investigator: James Hakim, MD, MSc, FRCP         
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: June 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014