Trial record 4 of 5 for:
NIAID | Open Studies | Exclude Unknown | HPV OR Human Papillomavirus OR genital warts OR oral warts
HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women
This study is currently recruiting participants.
Verified October 2012 by AIDS Clinical Trials Group
Sponsor:
AIDS Clinical Trials Group
Collaborator:
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01315353
First received: March 14, 2011
Last updated: October 24, 2012
Last verified: October 2012
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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: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (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
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: | October 24, 2012 |
| 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 May 21, 2013