Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006171
First received: August 10, 2000
Last updated: February 19, 2014
Last verified: June 2012
  Purpose

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.


Condition
HIV Seropositivity
Kaposi's Sarcoma
HIV Infections

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 24
Study Start Date: August 2000
Estimated Study Completion Date: June 2012
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 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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006171

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Yarchoan, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006171     History of Changes
Obsolete Identifiers: NCT00020319
Other Study ID Numbers: 000193, 00-C-0193
Study First Received: August 10, 2000
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HHV-8
Pathophysiology
AIDS
Cancer
Anti-Retroviral
Kaposi's Sarcoma
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on August 18, 2014