Know Cancer

or
forgot password

Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART


N/A
13 Years
N/A
Not Enrolling
Female
HIV Infections, Papilloma

Thank you

Trial Information

Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART


HIV infection is a significant risk factor for human HPV infection and the development of
HPV-associated lesions in the female genital tract. Findings suggest that HIV infection
and/or HIV-related immunosuppression increases a woman's susceptibility to HPV infection or
alters the natural history of preexisting HPV infection. Treatment with HAART has been shown
to result in significant increases in CD4+ cell counts and "partial reconstitution" of the
immune system. It is not known whether treatment of HIV infection with potent antiretroviral
regimens could affect the persistence of HPV infection and progression of cervical
dysplasia. This study is important for HIV-infected women because of the implications for
gynecologic management and determination of cervical disease risk.

At baseline, Weeks 24 and 48, and then every 48 weeks until study completion, women undergo
pelvic examination and cervical specimens collection by the following methods: 1) Sno-strip;
2) cervicovaginal lavage; 3) cervical brush method; and 4) Pap smear. A colposcopy is
required for any woman who has an abnormal Pap smear reading unless the abnormal Pap smear
is thought to be due to an intercurrent infection. A cervical biopsy is strongly
recommended in the event of an abnormal colposcopy. Blood is collected for HPV antibody
testing, viral load, and CD4 measures.

Inclusion Criteria


Inclusion Criteria

Women may be eligible for this study if they:

- Are HIV-positive.

- Are at least 13 years of age and menstruating.

- Are willing to enroll in another drug study.

- Have written consent of a parent or guardian if under 18 years.

- This study has been changed to increase enrollment. Women who are starting
HAART-based therapy prescribed by a personal physician or participating in an
antiretroviral trial are all eligible.

- Intend to start antiretroviral therapy within 14 days of study entry.

Exclusion Criteria

Women will not be eligible for this study if they:

- Have been on anti-HIV treatment for more than 14 days.

- Are abusing drugs or alcohol.

- Are receiving medication that affects the immune system, fights HPV, or is
investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or
III trial with approval of a study chair within 30 days of study entry, including but
not limited to systemic interferons and interleukins, thalidomide, systemic
cidofovir, and HPV vaccines. This study has been changed. The following medications
are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating
factor (G-CSF and filgrastim), and GM-CSF (sargramostim).

- Have cervical cancer or a history of cervical cancer.

- Have had a hysterectomy (removal of the uterus).

- Participated in HPV trials at any time.

- Use imiquimod inside the vagina.

- Are taking corticosteroid treatment in large doses.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Kathleen Squires

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

A5029

NCT ID:

NCT00006444

Start Date:

November 2000

Completion Date:

August 2005

Related Keywords:

  • HIV Infections
  • Papilloma
  • Drug Therapy, Combination
  • Papillomavirus, Human
  • DNA, Viral
  • Anti-HIV Agent
  • Treatment Naive
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Papilloma

Name

Location

San Mateo County AIDS ProgramSan Mateo, California  94305
Children's Hosp of Los Angeles/UCLA Med CtrLos Angeles, California  900276016
Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Univ of Rochester Medical CenterRochester, New York  14642
Julio ArroyoWest Columbia, South Carolina  29169
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
Univ of Miami School of MedicineMiami, Florida  331361013
Northwestern Univ Med SchoolChicago, Illinois  60611
Indiana Univ HospIndianapolis, Indiana  462025250
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Univ of North CarolinaChapel Hill, North Carolina  275997215
Duke Univ Med CtrDurham, North Carolina  27710
Johns Hopkins HospBaltimore, Maryland  21287
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Univ of Southern California / LA County USC Med CtrLos Angeles, California  900331079
Beth Israel Med CtrNew York, New York  10003
Univ of HawaiiHonolulu, Hawaii  96816
Methodist Hosp of Indiana / Life Care ClinicIndianapolis, Indiana  46202
Montefiore Med Ctr Adolescent AIDS ProgramBronx, New York  10467
Columbia Presbyterian Med CtrNew York, New York  100323784
MetroHealth Med CtrCleveland, Ohio  441091998
Case Western Reserve UnivCleveland, Ohio  44106
Univ of Miami (Pediatric)Miami, Florida  33161
Emory UnivAtlanta, Georgia  30308
Willow ClinicMenlo Park, California  94025
Brigham and Women's HospBoston, Massachusetts  02215
Mt Sinai Hosp Med Ctr / Dept of PediatricsChicago, Illinois  60608
Univ of California, San DiegoSan Diego, California  92103
Howard Univ HospWashington, District of Columbia  20060
North Broward Hosp DistrictFort Lauderdale, Florida  33311
Univ of Florida Health Science Ctr / PediatricsJacksonville, Florida  32209
State Univ of New York at Stony BrookStony Brook, New York  117948111
University of California San FranciscoSan Francisco, California  941104206
Stanford UnivStanford, California  94305-5107
Univ of Colorado Health Sciences Ctr, DenverDenver, Colorado  80262-3706
Univ of Miami / Jackson Memorial HospMiami, Florida  33136
The CORE CtrChicago, Illinois  60612
Wishard HospIndianapolis, Indiana  46202
Univ of Maryland (Pediatric)Baltimore, Maryland  20201
Univ of Maryland, Institute of Human VirologyBaltimore, Maryland  21201
Boston Med Ctr (Harvard)Boston, Massachusetts  02118
Boston Med Ctr (Pediatric)Boston, Massachusetts  02118
Community Health NetworkRochester, New York  14642-001
Univ of PittsburghPittsburgh, Pennsylvania  15213
Brown Univ / The Miriam HospProvidence, Rhode Island  02906
Miriam Hosp / Brown UnivProvidence, Rhode Island  02906
Brown Univ / Miriam HospProvidence, Rhode Island  02906
University of Washington (Seattle)Seattle, Washington  98104