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

13 Years
Not Enrolling
HIV Infections, Papilloma

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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:


Study Design:


Principal Investigator

Kathleen Squires

Investigator Role:

Study Chair


United States: Federal Government

Study ID:




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



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