Status:
COMPLETED
IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Positive
Malnourished
Eligibility:
All Genders
6-36 years
Phase:
PHASE4
Brief Summary
Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV)...
Detailed Description
P1092 was a prospective, non-randomized Phase IV open label study of antiretroviral drugs zidovudine (ZDV), lamivudine (3TC), and ritonavir boosted lopinavir (LPV/r) in children living with HIV aged 6...
Eligibility Criteria
Inclusion
- Documentation of HIV-1 infection defined as positive results from two samples collected at different time points, using protocol-specified tests
- Meets WHO classification for severe malnutrition, normal nutrition status, or mild malnutrition
- Eligible for HAART defined by WHO 2013 pediatric guidelines
- Parent or legal guardian able and willing to provide signed informed consent, remain within the study area during the study period and agree to have subject followed at the clinical site
- Qualifying hematology and chemistry laboratory values obtained from specimens collected within the study-specific screening period
- For severely malnourished children: An inpatient in a nutrition rehabilitation unit. Clinical improvement after 10-18 days on nutrition rehabilitation defined as: Appetite returned and eating better - child shows interest in food even if does not complete amount given:
- No further weight loss
- Normalized sodium and potassium defined as severity grade 1 or lower
- No evidence of cardiac failure
- Loss of apathy and starting to play
- No hypothermia or pyrexia - temperature stable at \>35.0 to \<38.0° C (non-axillary) or \>34.4 to \<37.4° C (axillary)
- For children with normal - mild malnutrition, clinical stability will be indicated by:
- Good appetite
- Normalized sodium and potassium defined as severity grade 1 or lower
- No hypothermia or pyrexia - temperature stable at \>35.0 to \<38.0° C (non-axillary) or \>34.4 to \<37.4° C (axillary)
Exclusion
- Edematous malnutrition at the time of study entry
- ≥ Grade 3 respiratory distress or presence of cardio respiratory compromise within 3 days prior to entry
- Chemotherapy for malignancy
- Acute infection for which the child has received appropriate antimicrobial treatment for \<5 days
- Tuberculosis disease
- Clinic hepatitis as evidenced by jaundice and hepatomegaly
- Taking any disallowed medications
- Any condition, situation, or clinical finding that in the opinion of the investigator would place the child at an unacceptable level of risk for injury, or render the child/caregiver(s) unable to meet the requirements of the study, interfere with study participation, or in the interpretation of study results.
Key Trial Info
Start Date :
October 26 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01818258
Start Date
October 26 2015
End Date
September 29 2017
Last Update
August 12 2021
Active Locations (5)
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1
Blantyre CRS (30301)
Blantyre, Malawi
2
Malawi CRS (12001)
Lilongwe, Malawi
3
Kilimanjaro Christian Medical Centre (5118)
Moshi, Tanzania
4
Makerere University-Johns Hopkins University (MUJHU) Research Collaboration (30293)
Kampala, Uganda