HIV Infections Clinical Trial
Official title:
Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
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.
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