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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

13 Years
Not Enrolling
HIV Seropositivity, Kaposi's Sarcoma, HIV Infections

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Trial Information

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


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.


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.


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


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


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

Type of Study:


Study Design:


Principal Investigator

Kevin A Camphausen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

June 2012

Related Keywords:

  • HIV Seropositivity
  • Kaposi's Sarcoma
  • HIV Infections
  • HHV-8
  • Pathophysiology
  • AIDS
  • Cancer
  • Anti-Retroviral
  • Kaposi's Sarcoma
  • HIV
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Seropositivity
  • Sarcoma, Kaposi
  • Sarcoma



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