Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006171
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2000-08-10
Brief Title:
Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of the Effects of Potent Anti-HIV Therapy on Parameters Hypothesized to be Related to the Pathogenesis of Kaposis Sarcoma KS in HIV-Infected Individuals
Status:
COMPLETED
Status Verified Date:
2012-06-29
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:
Background
Kaposi s sarcoma KS is caused by a gammaherpesvirus called Kaposi s sarcoma-associated herpesvirus KSHV or human herpesvirus-8 HHV-8 However infection with KSHV is not sufficient to cause KS and HIV infection is an important cofactor Treatment of HIV with potent antiretroviral therapy can reduce the risk of KS and can also induce regression in patients with established HIV-KS One mechanism by which HIV is believed to contribute to KS is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV andor KS itself However other mechanisms may also contribute
Objectives
One primary objective is to assess the effects of the initiation of potent anti-HIV therapy on specific factors possibly linked to the control or pathogenesis of KS namely serum viral IL-6 and plasma VEGF levels in patients with KS or at risk for KS by virtue of being infected with KSHVHHV-8 Another is to assess the effects of anti-HIV therapy on KSHV infection Secondary objectives are to assess the effects of potent antiretroviral therapy on established KS and other factors related to KS or KSHV infection
Eligibility
The principal eligibility factors are age 13 or above HIV infection and either KS or infection with KSHV Exclusion factors include KS that requires specific therapy recent corticosteroid therapy recent cytokine therapy or opportunistic infections requiring therapy
Design
Patients will be treated with potent antiretroviral therapy For patients with established KS the effects of the therapy on the KS will be monitored In addition a variety of factors related to KS HIV infection therapy or KSHV infection will be monitored These include the HIV viral load KSHV secretion in saliva the CD4 count serum VEGF levels and serum IL-6 levels
Kaposi s sarcoma KS is caused by a gammaherpesvirus called Kaposi s sarcoma-associated herpesvirus KSHV or human herpesvirus-8 HHV-8 However infection with KSHV is not sufficient to cause KS and HIV infection is an important cofactor Treatment of HIV with potent antiretroviral therapy can reduce the risk of KS and can also induce regression in patients with established HIV-KS One mechanism by which HIV is believed to contribute to KS is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV andor KS itself However other mechanisms may also contribute
Objectives
One primary objective is to assess the effects of the initiation of potent anti-HIV therapy on specific factors possibly linked to the control or pathogenesis of KS namely serum viral IL-6 and plasma VEGF levels in patients with KS or at risk for KS by virtue of being infected with KSHVHHV-8 Another is to assess the effects of anti-HIV therapy on KSHV infection Secondary objectives are to assess the effects of potent antiretroviral therapy on established KS and other factors related to KS or KSHV infection
Eligibility
The principal eligibility factors are age 13 or above HIV infection and either KS or infection with KSHV Exclusion factors include KS that requires specific therapy recent corticosteroid therapy recent cytokine therapy or opportunistic infections requiring therapy
Design
Patients will be treated with potent antiretroviral therapy For patients with established KS the effects of the therapy on the KS will be monitored In addition a variety of factors related to KS HIV infection therapy or KSHV infection will be monitored These include the HIV viral load KSHV secretion in saliva the CD4 count serum VEGF levels and serum IL-6 levels
Detailed Description:
Background
Kaposi s sarcoma KS is caused by a gammaherpesvirus called Kaposi s sarcoma-associated herpesvirus KSHV or human herpesvirus-8 HHV-8 However infection with KSHV is not sufficient to cause KS and HIV infection is an important cofactor Treatment of HIV with potent antiretroviral therapy can reduce the risk of KS and can also induce regression in patients with established HIV-KS One mechanism by which HIV is believed to contribute to KS is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV andor KS itself However other mechanisms may also contribute
Objectives
One primary objective is to assess the effects of the initiation of potent anti-HIV therapy on specific factors possibly linked to the control or pathogenesis of KS namely serum viral IL-6 and plasma VEGF levels in patients with KS or at risk for KS by virtue of being infected with KSHVHHV-8 Another is to assess the effects of anti-HIV therapy on KSHV infection Secondary objectives are to assess the effects of potent antiretroviral therapy on established KS and other factors related to KS or KSHV infection
Eligibility
The principal eligibility factors are age 13 or above HIV infection and either KS or infection with KSHV Exclusion factors include KS that requires specific therapy recent corticosteroid therapy recent cytokine therapy or opportunistic infections requiring therapy
Design
Patients will be treated with potent antiretroviral therapy For patients with established KS the effects of the therapy on the KS will be monitored In addition a variety of factors related to KS HIV infection therapy or KSHV infection will be monitored These include the HIV viral load KSHV secretion in saliva the CD4 count serum VEGF levels and serum IL-6 levels
Kaposi s sarcoma KS is caused by a gammaherpesvirus called Kaposi s sarcoma-associated herpesvirus KSHV or human herpesvirus-8 HHV-8 However infection with KSHV is not sufficient to cause KS and HIV infection is an important cofactor Treatment of HIV with potent antiretroviral therapy can reduce the risk of KS and can also induce regression in patients with established HIV-KS One mechanism by which HIV is believed to contribute to KS is through HIV-induced immunodeficiency which leads to a loss of immunologic control of KSHV andor KS itself However other mechanisms may also contribute
Objectives
One primary objective is to assess the effects of the initiation of potent anti-HIV therapy on specific factors possibly linked to the control or pathogenesis of KS namely serum viral IL-6 and plasma VEGF levels in patients with KS or at risk for KS by virtue of being infected with KSHVHHV-8 Another is to assess the effects of anti-HIV therapy on KSHV infection Secondary objectives are to assess the effects of potent antiretroviral therapy on established KS and other factors related to KS or KSHV infection
Eligibility
The principal eligibility factors are age 13 or above HIV infection and either KS or infection with KSHV Exclusion factors include KS that requires specific therapy recent corticosteroid therapy recent cytokine therapy or opportunistic infections requiring therapy
Design
Patients will be treated with potent antiretroviral therapy For patients with established KS the effects of the therapy on the KS will be monitored In addition a variety of factors related to KS HIV infection therapy or KSHV infection will be monitored These include the HIV viral load KSHV secretion in saliva the CD4 count serum VEGF levels and serum IL-6 levels
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 |
|---|---|---|---|
| 00-C-0193 | None | None | None |