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Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)


N/A
13 Years
N/A
Not Enrolling
Both
HIV Infections, Anus Neoplasms

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Trial Information

Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)


Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with
HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been
observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV,
compared to people with either disease alone. Studies that have investigated the effect of
highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been
contradictory and inconclusive. The role of CD4 count and HIV suppression and their
contributions to the progression of anal disease needs to be determined. This trial is a
substudy of a study of management of antiretroviral therapy (SMART). In the SMART study,
patients will participate in one of two strategies: a drug conservation (DC) strategy and a
viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then
receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of
at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral
load as low as possible, regardless of CD4 count. This study will compare the times to
development of high-grade anal dysplasia or anal cancer in participants who are currently
enrolled in the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. At the
baseline visit, participants will undergo an anal swab; some female participants will have a
cervical swab as well. Participants will provide a detailed sexual history including
sexually transmitted infections, a history of anal-related conditions, and a history of
alcohol and recreational drug use. These procedures will be repeated at each annual
follow-up visit. Some participants may undergo additional anal cytology and high-resolution
anoscopy with biopsy. Participants will be followed until they develop high-grade anal
dysplasia or anal cancer or when the SMART study closes, whichever comes first.


Inclusion Criteria:



- Coenrollment in the SMART study

- Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution
anoscopy must be performed and specimens must be obtained.

- Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

- Current or prior history of anal or cervical cancer

- Permanent or irreversible bleeding disorder that would interfere with biopsy of the
anal canal

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Time to high-grade anal dysplasia or anal cancer

Principal Investigator

Calvin Cohen, MD, MSc

Investigator Role:

Study Chair

Investigator Affiliation:

Community Research Initiative of New England

Authority:

United States: Federal Government

Study ID:

CPCRA 065G

NCT ID:

NCT00107679

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Anus Neoplasms
  • Treatment Experienced
  • HIV
  • HPV
  • Antiretroviral Therapy, Highly Active
  • Papillomavirus, Human
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Anus Neoplasms
  • Neoplasms

Name

Location

SUNY Downstate Medical CenterBrooklyn, New York  11203
Raritan Bay Medical CenterPerth Amboy, New Jersey  08861
Yale UniversityNew Haven, Connecticut  06520
Providence Portland Medical CenterPortland, Oregon  97213-3635
Kaiser PermanentePortland, Oregon  97227
Harper HospitalDetroit, Michigan  48201
Los Angeles Gay and Lesbian Community Service CenterLos Angeles, California  90028
VA Greater Los Angeles Healthcare SystemLos Angeles, California  90073
UCSF AIDS ClinicSan Francisco, California  94110
San Francisco VA Medical CenterSan Francisco, California  94110
William Owen, M.D.San Francisco, California  94110
Dr. Shawn HasslerSan Francisco, California  94110
Positive Health Pratice at San Francisco General HospitalSan Francisco, California  94110
Dr. R. ScottSan Francisco, California  94110
Virginia Cafaro, MDSan Francisco, California  94110
Castro-Mission Health CenterSan Francisco, California  94110
Dr. M. EstesSan Francisco, California  94110
East Bay AIDS Ctr (Jacobson, Borkert, OBrien)San Francisco, California  94110
Denver Public HealthDenver, Colorado  80204-4507
University Hospital Infectious Diseases ClinicDenver, Colorado  80204-4507
Western Infectious Disease ConsultantsDenver, Colorado  80204-4507
Denver Public Health/Eastside Health CenterDenver, Colorado  80204-4507
Denver Public Health/Westside Family Health CenterDenver, Colorado  80204-4507
Drs. Lichtenstein & GreenbergDenver, Colorado  80204-4507
Kaiser PermanenteDenver, Colorado  80204-4507
S. Denver Infectious Diseases SpecialistsDenver, Colorado  80204-4507
Boulder Community Hospital/Beacon ClinicDenver, Colorado  80204-4507
Apex Family MedicineDenver, Colorado  80204-4507
CRI-BrooklinNew Haven, Connecticut  06510-2483
CRI-SpringfieldNew Haven, Connecticut  06510-2483
Washington VAWashington, District of Columbia  20422
Henry Ford Hospital AIDS ClinicDetroit, Michigan  48202
Detroit Receiving Hospital-University Health CenterDetroit, Michigan  48201
Detroit Community Health ConnectionDetroit, Michigan  48201
Kennedy Memorial Hospital/Early Intervention ProgramCamden, New Jersey  08103
Cooper Hospital/ The Early Intervention CenterCamden, New Jersey  08103
HHC Outpatient ClinicsNew York, New York  10039
Multomah County Health DepartmentPortland, Oregon  97209-2534
The R & E Group OfficePortland, Oregon  97209-2534
Legacy Clinic NEPortland, Oregon  97209-2534
Legacy Clinic at Good SamaritanPortland, Oregon  97209-2534
Temple University School of MedicinePhiladelphia, Pennsylvania  19140
Thomas Street Clinic- The University Texas - HoustonHouston, Texas  77030
Houston Veterans Affairs Medical CenterHouston, Texas  77030-4211
Thomas Clinic Baylor College of MedicineHouston, Texas  77009
Vernon J. Harris East End Community Health Care Ctr.Richmond, Virginia  23219
Dr. Ronald ArtzRichmond, Virginia  23298
MediCorp, Infectious Disease AssociatesRichmond, Virginia  23298
Infectious Disease ClinicRIchmond, Virginia  23298
South Richmond Health CenterRichmond, Virginia  23219
Cross-Over ClinicRichmond, Virginia  23219
Petersburg Health Care AllianceRichmond,, Virginia  23298