Viewing Study NCT00070980



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Study NCT ID: NCT00070980
Status: COMPLETED
Last Update Posted: 2006-08-18
First Post: 2003-10-09

Brief Title: Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Sponsor: National Center for Complementary and Integrative Health NCCIH
Organization: National Center for Complementary and Integrative Health NCCIH

Study Overview

Official Title: Massage to Enhance Well-Being in HIV-Positive Dominican Children
Status: COMPLETED
Status Verified Date: 2006-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV
Detailed Description: The incidence of pediatric HIV in the Dominican Republic has been rapidly rising while antiretroviral therapies are not yet readily available to slow disease progression There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults even in the absence of antiretroviral treatments In studies with premature newborns increased weight gain decreased stress behavior and more optimal cognitive and motor development have been reported following massage treatment This study will examine the efficacy of massage therapy an affordable and potentially beneficial complementaryalternative treatment to promote health and enhance well-being in HIV infected children in the Dominican Republic

Children will be randomly assigned to receive either massage therapy or standard carefriendly visits twice weekly for 12 weeks Data will be gathered to assess acceptance safety and compliance to massage therapy and to examine whether massage treatment has improved immune function developmental performance and behavioral function

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None