Status:
COMPLETED
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
Brief Summary
To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-I...
Detailed Description
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 c...
Eligibility Criteria
Inclusion Criteria
Patients must have the following:
- HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
- Legally qualified guardian with the ability to sign a written, informed consent form.
- Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
- Anticipated life expectancy of at least 3 months.
Prior Medication:
Allowed:
- Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
- Gamma globulin as prophylaxis for measles and varicella.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
- Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
- Echocardiogram values > 2 standard deviations from normal.
- Hematologic, renal, or hepatic insufficiency.
Concurrent Medication:
Excluded:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
- Cancer chemotherapy.
- Corticosteroids.
- Other known immunomodulatory agents.
- Other experimental therapy not specifically allowed.
Patients with the following are excluded:
- Hematologic, renal, or hepatic insufficiency.
- Past or present history of any serious active opportunistic infection.
Prior Medication:
Excluded for a minimum of 3 weeks prior to study entry:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG).
- Cancer chemotherapy.
- Immunomodulatory agents.
- Acyclovir and other experimental therapy.
Risk Behavior:
Excluded:
- Patients born to substance abusing mothers (including alcohol) during the pregnancy.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00000663
Last Update
June 24 2005
Active Locations (7)
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1
UCSD Treatment Ctr
San Diego, California, United States, 92103
2
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
3
Cook County Hosp
Chicago, Illinois, United States, 60612
4
Tulane Univ Med School
New Orleans, Louisiana, United States, 70112