The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women
The purpose of this study is to see how often human papillomavirus (HPV) occurs in
 HIV-infected women who have not taken anti-HIV drugs and to learn whether taking anti-HIV
 drugs will affect HPV in women.

 HIV infection increases the risk of getting HPV infection. Findings suggest that HIV
 infection as well as a weakened immune system may increase the chances of getting HPV.
 Aggressive anti-HIV medication has been shown to strengthen the immune system. Researchers
 want to learn whether anti-HIV drugs affect the HPV virus or decrease the chances of getting
 HPV. This study is important because it may provide important information to help manage a
 woman's health and to determine a woman's risk for developing problems with the cervix (outer
 end of the uterus).
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

 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.