Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma
| Status: | Completed |
|---|---|
| Conditions: | Cancer, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 4/6/2019 |
| Start Date: | August 7, 2000 |
| End Date: | June 29, 2012 |
A Study of the Effects of Potent Anti-HIV Therapy on Parameters Hypothesized to be Related to the Pathogenesis of Kaposi's Sarcoma (KS) in HIV-Infected Individuals
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
and/or 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 KSHV/HHV-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
and/or 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 KSHV/HHV-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.
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
and/or 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 KSHV/HHV-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
and/or 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 KSHV/HHV-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.
- INCLUSION CRITERIA:
Age greater than or equal to 13 years
HIV seropositive
Either a diagnosis of Kaposi's sarcoma and/or HHV-8/KSHV seropositive
EXCLUSION CRITERIA:
Requirement for specific anti-KS therapy
Specific anti-KS therapy within 4 weeks of study entry
Corticosteroid therapy within 4 weeks prior to initiating study
Condition that periodically requires immune suppressive therapy (e.g. asthma)
Cytokine therapy within 4 weeks of study entry
HIV-associated opportunistic complications requiring therapy
Inability to provide informed consent
Investigator recommendation that antiretroviral therapy is in best patient interest
Inability to comply with protocol
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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