Status:
COMPLETED
HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
HIV Infections
Eligibility:
All Genders
2-10 years
Phase:
PHASE3
Brief Summary
HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in...
Detailed Description
This is an open label, single site, randomized clinical trial comparing PI-based ART to NNRTI-based ART for the prevention of malaria in HIV-infected children. The two ART drug regimens that will be u...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 2 months to \< 11 years
- Confirmed HIV diagnosis. i. Children \> 18 months: Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test ii. Children \< 18 months: Documentation will be DNA PCR confirmation only along with documentation of testing from the referral entity
- ART-naïve patients eligible for ART initiation per WHO/Uganda guidelines (see Table 1) or Patients receiving first line ART regimen with NNRTI +2 NRTI with at least one HIV RNA \<400 copies/ml within the past 6 months
- Agreement to come to the study clinic for any febrile episode or other illness
- Agreement to avoid medications administered outside study protocol
- Provision of informed consent by parent/guardian and agreement to have child's care at the clinical site
- Lives within 50 km of study site
- Exclusion criteria:
- ART-naïve children: children or their mothers that have received any dose of Nevirapine in the past 24 months
- Active medical problem requiring in-patient evaluation at the time of screening or enrollment
- History of cardiac conduction disorder or known significant cardiac structural defect
- Children receiving any disallowed medications (see section 4.3)
- Moderate, Severe or Life-threatening (Grade 2, 3, or 4) AST or ALT found within 4 weeks prior to enrollment:
- AST: \>113U/L (\>2.5xULN)
- ALT: \>113U/L (\>2.5xULN)
- Life-threatening (Grade 4) screening laboratory value found within 4 weeks prior to enrollment for the following:
- Absolute neutrophil count: \<500 mm3
- Hemoglobin: \<6.5 g/dL
- Creatinine: \>3.5xULN
- Platelets: \<25,000/mm3
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00978068
Start Date
September 1 2009
End Date
January 1 2013
Last Update
December 28 2018
Active Locations (1)
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1
IDRC - Tororo Research Clinic
Tororo, Uganda