Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma

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.

• 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