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DOT-HAART

Phase 3

HIV | Unknown | Infectious Disease |Harvard Bioscience, Inc.|Last Updated: Oct 25, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,244
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01070017Community-based Accompaniment With Supervised Antiretrovirals in Lima, PeruPHASE3 COMPLETED 1,244Feb 1, 2010Aug 1, 2014Oct 25, 20171 Peru
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Study Endpoints
Primary Endpoints
Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
18 and 24 months
Secondary Endpoints
Identify mediating mechanisms of CASA effect on individual outcomes.
24 months
Identify subgroups who respond best to CASA intervention.
24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
Intervention: DOT-HAARTEXPERIMENTALIntervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
No DOT-HAARTNO_INTERVENTIONControl group receives community-based monthly adherence visits and standard care, but no DOT-HAART.
Interventions
NameTypeDescription
DOT-HAARTOTHERFor 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria for Patient Cohort: * Age greater than or equal to 18; * Diagnosis if HIV and meeting criteria for HAART; * Lives in poverty; * EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure; * Documentation of baseline CD4 cell count and HIV load; * Residence and...

Countries:Peru
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