A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children (NCT00000827) | Clinical Trial Compass
CompletedPhase 1
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
United States45 participants
Plain-language summary
To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.
Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
Who can participate
Age range2 Years – 12 Years
SexALL
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Inclusion Criteria
Concurrent Medication:
Required:
* PCP prophylaxis according to CDC guidelines.
Allowed:
* Varicella-zoster immunoglobulin.
* Hepatitis B immunoglobulin.
* Prophylactic therapies not involving immunoglobulin.
Patients must have:
* HIV infection.
* CD4 count \> 200 cells/mm3 (ages 2-5 years) or \> 100 cells/mm3 (age \> 5 years).
* Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.
* Plasma ICD p24 \>= 70 pg/ml that is stable or increasing prior to study entry.
* Life expectancy of at least 6 months.
Prior Medication: Required:
* Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.
* Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).
* Acute illness with temperature \>= 100 F and/or with IV antibiotics.
* Grade 3 or worse clinical toxicities.
* Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.
* Concomitant participation in an experimental antiretroviral or HIV vaccine trial.
Concurrent Medication:
Excluded:
* IVIG.
* Chemotherapy for an active malignancy.
* MMR or rubella vaccinations.
* Intramuscular immunoglobulin.
Patients with the following prior condition are excluded:
* History of …
Trial details
NCT IDNCT00000827
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)