Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

September 8, 2011

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
KSHV Inflammatory Cytokine Syndrome (KICS)KSHVHHV-8
Interventions
DRUG

Zidovudine

Zidovudine 600 mg will be administered orally 4 times a day or i.v. at 300 mg every 6 hours for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

DRUG

Liposomal Doxorubicin

Liposomal doxorubicin (20 mg/m2) will be administered i.v. over 1 hour at day 1 of each cycle

DRUG

Valganiclovir

Valganciclovir (900mg) will be administered orally twice/day or Ganciclovir (5 mg/kg) will be administered i.v. over 1 hour for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.

DRUG

Rituximab

"Rituximab (375 mg/m2) will be admnistered i.v. at 50 mg/hr up to 100 mg/hr at day 1 of the first cycle and at 100mg/hr up to 400 mg~/hr at day 1 of following cycles."

OTHER

Standard Therapies

Standard of Care drugs

OTHER

Cohort 1

Participants who are infected with KSHV who meet criteria for inflammatory cytokine syndrome (KICS)

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01419561 - Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) | Biotech Hunter | Biotech Hunter