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Home > "E" Clinical Trials Conditions > Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma  Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
For Condition: HIV Seropositivity,HIV Infections,Kaposi's Sarcoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: This is a study to gain preliminary information on the effect of highly active antiretroviral therapy (HAART) on the antitumor activity and on pathophysiologic mechanisms of AIDS-associated Kaposi's sarcoma (KS). Since the development of KS is dependent on the presence of infection with the Kaposi's sarcoma-associated herpes virus (KSHV), it is postulated that HIV affects the development of KS in part through its affect on KSHV and on angiogenic factors directly or indirectly induced by KSHV. In addition, it is postulated that the immune dysfunction induced by HIV may affect the development of KS through its effect on KSHV or on angiogenic factor production. Therefore, this protocol will assess a number of virologic, angiogenic, and immunologic parameters of HIV and KSHV in patients co-infected with these viruses and who are being treated with HAART. All patients must have evidence of KSHV infection, but overt KS is not required in all of the patients who will be enrolled. For patients with overt KS lesions, preliminary assessment will be made as to the anti-tumor effects of HAART.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 24
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 000193; 00-C-0193
Study Start Date: August 7, 2000
Record last reviewed: July 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006171
Other Hiv Infections Studies:
1. A Study of Saquinavir Soft Gelatin Capsules Combined with Other Anti-HIV Drugs in HIV-1 Infected Patients
2. A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
3. Double-Blind Comparison of the Efficacy of Continued Zidovudine versus 2',3'-Dideoxyinosine (ddI) (BMY-40900) for the Treatment of Patients With AIDS or AIDS-Related Complex and Increasing Symptomatology Despite Treatment with Zidovudine
4. The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients with AIDS and Advanced ARC
5. The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
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