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NCT00006171 · ClinicalTrials.gov registry record

Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma

A clinical trial, sponsored by National Cancer Institute (NCI).

Completed
Registry status
24
Enrollment target

NCT00006171: Completed study, sponsored by National Cancer Institute (NCI).

NCT00006171 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00006171 has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
24 participants
Enrollment target

Study 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.

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2000-08-07
Est. Completion 2012-06-29
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00006171 record still lists

NCT00006171 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00006171 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00006171 about?

NCT00006171 is a clinical study titled "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 antiretrovira...

What is the current status of trial NCT00006171?

This trial is currently completed. The enrollment target is 24 participants. The study started on 2000-08-07. Estimated completion is 2012-06-29.

Who is sponsoring clinical trial NCT00006171?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00006171, the US trial registry maintained by the National Library of Medicine. NCT00006171 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.