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ADOLESCENT Comparison studies of HIV+ adolescents w/depression, suicides and disclosure issues.  Rates of suicide and depression in general population of adolescents vs. HIV+. o Look at 219C DACS for this information.  Compare behaviorally infected vs. perinatally infected.  Look at diseases such as CF, Sickle Cell and Diabetes vs. HIV+. Hitting the Wall: Body begins to breakdown: Effects of long-term meds and metabolic disorders.  Years of living with HIV and taking anti-HIV meds. Follow-up  Feedback.  Results of study to participants.  Continuity of care in the event of moving.  Issues related to feedback and retention.  Include in future protocols requirements for participant feedback, information dissemination.  Create template for information dissemination. Other Issues and Concerns Raised Sexuality/Acceptance/Sexuality Issues and Preventive efforts related to disclosure issues:  Confidential/Anonymous CRF questions.  Sexual Practices/Self image/Body Images.  Disclosure to partners. Education vs. Ignorance:  Knowledge=Power: Provide information and allow educational materials to get caregivers and participants.  Create a CRF to document participant’s level of knowledge of understanding. How does HIV affect the uninfected adolescent: P1055/Partial coverage.


IMMUNOLOGY/VACCINE Develop vaccine to only boost immunity. (IN DEVELOPMENT)  If vaccine only boosts immunity will it be considered a treatment and standard of care? Other Issues and Concerns Raised Is use of placebo ethical?  Participants’ belief/hope that they are getting a cure. Will long-term survivors receive HIV vaccine first?

PERINATAL Children exposed to HIV and who have been exposed to AZT & Nevirapine and all interventions.  2 studies (IN DEVELOPMENT)  Children exposed to perinatal interventions: being studied. Other Issues and Concerns Raised Infected moms/caregivers without access to meds for themselves. (PUBLIC HEALTH ISSUE)  Complications/family care Outreach efforts to reduce transmission to <1% (PUBLIC HEALTH ISSUE)

COMPLICATIONS Growth Issues, Bones: meds? HIV?  Issues of poverty and nutrition - domestic & internationally. Mental Health Issues& Exposed Babies. (Perinatal) Effect of disclosure on health/adherence etc. (Ped/Adolescent/Perinatal) Other Issues and Concerns Raised If the virus or ARTs is affecting the brain, can this be counter-acted or resolved.  Long term concerns. (Adolescent) Long-term side effects/ADHD-ADD.  HIV meds inserts specify long and short-term effects. Puberty/Sexual development.  Dosing adjustments around puberty Access to meds to prevent OI’s such as Malaria/TB. 2

PRIMARY THERAPY Do children who have been suppressed for many years (I.e., 10 yrs) need to stay on heavy med regimens?  When to switch (IMMUNOLOGY RAC & ADOLESCENT RAC)  Drug interruption Study use of generic meds and non-traditional areas of boosting immune system.  Encourage DAIDS to use non-tradition methods and drugs.  Use of generic drugs. Novel agents: use of herbs etc. Other Issues and Concerns Raised If the child takes drugs likes to sleep during the day, is that not a problem at school.  Time of day dosing: Is it the meds keeping them up at night/ Making them sleepy during the day.  Is it the meds or depressions/social factors? Simple/ 1X day dosing: reduce dosing.


PLAN TO TAKE TO PACTG/IMPAACT LEADERSHIP AND RACS 1) Present to PACTG Leadership via RPS (Research Prioritization Subcommittee). 2) Present to IMPAACT (International Maternal AIDS/Adolescents Clinical Trials) Leadership. 3) Take to the HIV Prevention Trials Network (HPTN) Community. 4) Larger PACTG Community.

To following two areas are be discussed on an ongoing basis: WAYS TO GET PROTOCOLS DEVELOPED AND ACCRUED 1) Train the PCCG about protocol development. 2) Train larger community (CABs at the site level) about protocol development. 3) PACTG219C resource page. 4) Large session (plenary or Interactive – PSRC/Community) at October 2005 PACTG Meeting. 5) July 2005 CAB Retreat Session ACCESSIBILITY/BARRIERS OF RESEARCH TO FAMILIES 1) Int’l sites not permitted to use PACTG funds to pay for drugs to use on trial. 2) Build primary care sites at townships: