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 States, Puerto Rico45 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 range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000827
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)