Clinical trial · Observational
Effects of Potent Antiretroviral Therapy on Kaposi s Sarcoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| HIV Seropositivity | — | UNRESOLVED | — |
| Kaposi's Sarcoma | Kaposi Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
* 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
References
Publications (3)
- BACKGROUNDBiggar 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
- BACKGROUNDGoedert 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
- BACKGROUNDMartin 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