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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00006444 |
Purpose
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).
| Condition |
|---|
|
HIV Infections Papilloma |
| Study Type: | Observational |
| Official Title: | Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART |
| Estimated Enrollment: | 160 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Women may be eligible for this study if they:
Exclusion Criteria
Women will not be eligible for this study if they:
Contacts and Locations
Show 51 Study Locations| Study Chair: | Kathleen Squires | |
| Study Chair: | Rebecca Clark | |
| Study Chair: | Kenneth H Fife |
More Information
| Study ID Numbers: | ACTG A5029, AACTG A5029 |
| Study First Received: | November 3, 2000 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006444 History of Changes |
| Health Authority: | United States: Federal Government |
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Drug Therapy, Combination Papillomavirus, Human DNA, Viral Anti-HIV Agent Treatment Naive |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes Virus Diseases |
Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Neoplasms, Squamous Cell Papilloma Retroviridae Infections Neoplasms, Glandular and Epithelial |
