Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma

NCT00006171 | Completed

• 2 other identifiers: 00019300-C-0193
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV Seropositivity; Kaposi's Sarcoma; HIV Infections

Keywords

HHV-8; Pathophysiology; AIDS; Cancer; Anti-Retroviral; Kaposi's Sarcoma; HIV

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 13 years
• HIV seropositive
• Either a diagnosis of Kaposi's sarcoma and/or HHV-8/KSHV seropositive

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Biggar RJ, Rabkin CS. The epidemiology of AIDS--related neoplasms. Hematol Oncol Clin North Am. 1996 Oct;10(5):997-1010. doi: 10.1016/s0889-8588(05)70380-4.

  PMID: 8880192 BACKGROUND

• Goedert JJ, Cote TR, Virgo P, Scoppa SM, Kingma DW, Gail MH, Jaffe ES, Biggar RJ. Spectrum of AIDS-associated malignant disorders. Lancet. 1998 Jun 20;351(9119):1833-9. doi: 10.1016/s0140-6736(97)09028-4.

  PMID: 9652666 BACKGROUND

• Martin JN, Ganem DE, Osmond DH, Page-Shafer KA, Macrae D, Kedes DH. Sexual transmission and the natural history of human herpesvirus 8 infection. N Engl J Med. 1998 Apr 2;338(14):948-54. doi: 10.1056/NEJM199804023381403.

  PMID: 9521982 BACKGROUND

MeSH Terms

Conditions

HIV Seropositivity; Sarcoma, Kaposi; HIV Infections; Acquired Immunodeficiency Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpesviridae Infections; DNA Virus Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Slow Virus Diseases

Study Officials

• Robert Yarchoan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 10, 2000
• First Posted: August 11, 2000
• Study Start: August 7, 2000
• Study Completion: June 29, 2012
• Last Updated: December 12, 2019

Record last verified: 2012-06-29

Locations

US (1)