HIV SeropositivityNCT00006171
Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma
An observational study of HIV Seropositivity and Kaposi's Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Seropositivity, Kaposi's Sarcoma, HIV Infections
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2000to 29 Jun 2012
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 13 years
- HIV seropositive
- Either a diagnosis of Kaposi's sarcoma and/or HHV-8/KSHV seropositive
Who cannot join
- 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
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- Inability to provide informed consent
- Investigator recommendation that antiretroviral therapy is in best patient interest
- Inability to comply with protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- HIV Seropositivity, Kaposi's Sarcoma, HIV Infections
- Keywords
- HHV-8, Pathophysiology, AIDS, Cancer, Anti-Retroviral, Kaposi's Sarcoma, HIV
- Medical subject headings
- HIV Seropositivity, Sarcoma, Kaposi, HIV Infections, Acquired Immunodeficiency Syndrome, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2000 (estimated)
- Study start7 Aug 2000
- Study completion29 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert Yarchoan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006171
- Sponsor's protocol ID
- 000193
- Other IDs
- 00-C-0193
- Status last verified
- 29 Jun 2012
- First submitted
- 10 Aug 2000
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
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.
PubMed 8880192Goedert 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.
PubMed 9652666Martin 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.
PubMed 9521982