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OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

A longitudinal study with four parallel cohorts with each participant followed for 2 years: two cohorts in Busia (high malaria transmission site) and two cohorts in Kampala (low malaria transmission). Each site will have a cohort of children living with HIV (CLHIV) and HIV- uninfected children and will be age-matched, enrolled in parallel, and followed for two years. All children will be enrolled without malaria infection, as determined by a negative blood smear at baseline.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: t
View:

• Agreement to come to the clinic for all follow-up evaluations

• Provision of informed consent and assent (as appropriate)

• Residency within approximately 30 km of the study clinic

• Negative blood smear for malaria (all sites)

• For Children and adolescents living with HIV

‣ Confirmed HIV infection

⁃ On DTG-based regimen for ≥14 days

• For HIV-uninfected children - documentation of HIV-negative status by at least 1 assay

Locations
Other Locations
Uganda
Baylor- Uganda
RECRUITING
Kampala
Infectious Disease Research Collaboration (IDRC)
RECRUITING
Kampala
Contact Information
Primary
Sunil Parikh, MD, MPH
sunil.parikh@yale.edu
1-203-737-7906
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 380
Treatments
Experimental: CLHIV on DTG- Kampala (Cohort 1)
CLHIV on DTG living in the low transmission malaria setting of Kampala
No_intervention: HIV-uninfected children- Kampala (Cohort 2)
HIV-uninfected children living in the low malaria transmission site of Kampala (control)
Experimental: CLHIV on DTG- Busia (Cohort 3)
CLHIV on DTG living in the high malaria transmission site of Busia
No_intervention: HIV-uninfected children- Busia (Cohort 4)
HIV-uninfected children living in high malaria transmission site of Busia (control)
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov