Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006444
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2000-11-03
Brief Title:
The Effects of Combination Anti-HIV Medication on Human Papillomavirus HPV in HIV-Infected Women
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Assessment of Prevalence and Persistence of Human Papillomavirus HPV DNA in HIV-Infected Women Who Are Antiretroviral Naive and Have Initiated HAART
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans health and to determine a womans risk for developing problems with the cervix outer end of the uterus
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 womans health and to determine a womans 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 andor HIV-related immunosuppression increases a womans 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTG A5029 | None | None | None |
| AACTG A5029 | None | None | None |