Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067106
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2003-08-11
Brief Title:
Antiviral Therapy and HIV in the Female Genital Tract
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Antiviral Therapy and HIV in the Genital Tract of Women
Status:
COMPLETED
Status Verified Date:
2014-09
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:
HIV is found in both the blood and the genital tract This study will compare the levels and types of HIV found in the blood with the levels and types of HIV found in the female genital tract
Study hypotheses 1 In the presence of antiretroviral therapy viral replication within the female genital tract may lead to the development of drug resistance that is different from that of virus in the blood plasma 2 Antiretroviral drug levels in the female genital tract may often be lower than in the blood plasma and differences in drug exposure may be associated with differences in virus replication and selection of resistant HIV variants during drug failure 3 HIV can be recovered in vitro from cells in the female genital tract during successful therapy and it may be genetically different from the HIV variants recovered from the blood cell latent reservoir on the same visit
Study hypotheses 1 In the presence of antiretroviral therapy viral replication within the female genital tract may lead to the development of drug resistance that is different from that of virus in the blood plasma 2 Antiretroviral drug levels in the female genital tract may often be lower than in the blood plasma and differences in drug exposure may be associated with differences in virus replication and selection of resistant HIV variants during drug failure 3 HIV can be recovered in vitro from cells in the female genital tract during successful therapy and it may be genetically different from the HIV variants recovered from the blood cell latent reservoir on the same visit
Detailed Description:
Approximately 42 million adults are living with HIVAIDS The predominant mode of HIV transmission worldwide is through heterosexual contact While many behavioral and biologic factors are associated with sexual transmission of HIV viral load has been identified as the chief predictor of the risk of sexual transmission Research has shown a strong correlation between blood plasma viral load and genital tract viral load Antiretroviral medications can reduce blood plasma and genital tract HIV RNA levels but antiretrovirals also lead to drug resistant HIV In the United States and Europe 2 to 27 of newly infected patients are infected with drug resistant HIV There are reports of resistant genotypic variants in the genital tract that differ from variants found in the blood
Understanding the dynamics of HIV in the genital tract is of great importance in strategies to control transmission of HIV This study will evaluate the levels and variants of HIV in the blood and genital tracts of women taking antiretroviral medication
Both women who are failing their current antiretroviral regimen Group 1 and those who are fully suppressed on antiretroviral therapy Group 2 will be enrolled in this study Women in Group 1 will have study visits at study entry 2 weeks after changing medications then every 4 weeks until the amount of HIV in the blood and genital tract are undetectable Drug levels in the blood and genital tract will also be measured at the first visit and after changing medications Once the level of HIV is undetectable women will be seen every 3 months for 36 months Women in Group 1 will be followed no more than 42 months Women in Group 2 will have study visits for blood and genital tract collections at study entry and then every 4 weeks for 12 months
Understanding the dynamics of HIV in the genital tract is of great importance in strategies to control transmission of HIV This study will evaluate the levels and variants of HIV in the blood and genital tracts of women taking antiretroviral medication
Both women who are failing their current antiretroviral regimen Group 1 and those who are fully suppressed on antiretroviral therapy Group 2 will be enrolled in this study Women in Group 1 will have study visits at study entry 2 weeks after changing medications then every 4 weeks until the amount of HIV in the blood and genital tract are undetectable Drug levels in the blood and genital tract will also be measured at the first visit and after changing medications Once the level of HIV is undetectable women will be seen every 3 months for 36 months Women in Group 1 will be followed no more than 42 months Women in Group 2 will have study visits for blood and genital tract collections at study entry and then every 4 weeks for 12 months
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