|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | November 3, 2000 | ||||||||||||
| Last Updated Date | July 29, 2008 | ||||||||||||
| Start Date ICMJE | |||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00006444 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | The Effects of Combination Anti-HIV Medication on Human Papillomavirus (HPV) in HIV-Infected Women | ||||||||||||
| Official Title ICMJE | Assessment of Prevalence and Persistence of Human Papillomavirus (HPV) DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART | ||||||||||||
| Brief Summary | 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). |
||||||||||||
| Detailed Description | 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. |
||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | |||||||||||||
| Condition ICMJE |
|
||||||||||||
| Intervention ICMJE | |||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||
| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Enrollment ICMJE | 160 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Women may be eligible for this study if they:
Exclusion Criteria Women will not be eligible for this study if they:
|
||||||||||||
| Gender | Female | ||||||||||||
| Ages | 13 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States, Puerto Rico | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00006444 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | ACTG A5029, AACTG A5029 | ||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||||||
| Investigators ICMJE |
|
||||||||||||
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | August 2004 | ||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||