Protocol Number: 00-C-0193

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

Number:

00-C-0193

Summary:

This study will examine the effects of potent anti-HIV therapy on factors thought to be involved in causing Kaposi's sarcoma (KS) in patients with HIV infection or KS. These include certain blood proteins and a virus called Kaposi's sarcoma-associated herpes virus, or KSHV. (This virus is also called human herpes virus-8, or HHV-8). Patients in this study will receive standard treatment; experimental therapy is not used.

HIV-infected patients 13 years of age and older with KS or whose blood tests positive for KSHV may be eligible for this study. Candidates will be screened with a history, physical examination and blood tests for HIV and KSHV.

Participants will receive up to 2 years of a combination of anti-HIV drugs while on the study. (Patients who are already taking antiviral therapy when they join the study will have their medications stopped for 4 weeks, during which blood tests will be done to measure the effects of stopping treatment on KSHV and other factors. Therapy will then be restarted.) During the study period, blood and saliva samples will be tested for any changes in immune function directed at KSHV and blood proteins that may be linked with KS. Patients who have KS lesions will have their lesions biopsied for microscopic examination of possible immune-related changes. (A biopsy is removal of a small tissue sample under local anesthetic.) Patients with KS lesions will also be evaluated for clinical response to treatment.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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

Either:

No prior HIV therapy;

Requirement for change in HIV therapy and naive to at least two anti-HIV drugs;

On effective therapy but willing to suspend therapy for at least 4 weeks.

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

Special Instructions: Currently Not Provided

Keywords:

HHV-8

Pathophysiology

AIDS

Cancer

Anti-Retroviral

Recruitment Keywords:

Kaposi's Sarcoma

HIV

Conditions:

HIV Seropositivity

Kaposi's Sarcoma

HIV Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

The epidemiology of AIDS-related neoplasms

Spectrum of AIDS-associated malignant disorders

Sexual transmission and the natural history of human herpesvirus 8 infection

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004