Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Status and phase
Completed
Phase 2
Phase 1
Conditions
HIV Infections
Treatments
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
Details and patient eligibility
About
The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.
Enrollment
56 patients
Sex
All
Ages
3 months to 6 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- HIV-1 infected; >=3 months of age to <=6 years of age (at time of treatment); screening plasma viral load >=1000 copies/mL
Exclusion criteria
- Genotypic or phenotypic resistance to EFV, ddl, or FTC/lamivudine (3TC) at screening
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
56 participants in 4 patient groups
EFV+ddI+FTC in patients >= 3 months to < 6 months
Experimental group
Description:
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Treatment:
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
EFV+ddI+FTC in patients >=6 months to < 2 years
Experimental group
Description:
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Treatment:
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
EFV+ddI+FTC in patients >= 2 years to < 3 years
Experimental group
Description:
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Treatment:
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
EFV+ddI+FTC in patients >= 3 years to <= 6 years
Experimental group
Description:
EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle, or oral solution (30 mg/mL. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m\^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Treatment:
Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
Trial contacts and locations
17
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Data sourced from clinicaltrials.gov
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