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
NCT ID: NCT00000663
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
Brief Summary
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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 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
Detailed Description
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Patients receive one intravenous injection the first week, followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age; (2) Infants 0-3 months of age.
Conditions
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Study Design
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TREATMENT
Interventions
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CD4-IgG
Eligibility Criteria
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Inclusion Criteria
* 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
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.
1 Day
5 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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R Yogev
Role: STUDY_CHAIR
W Shearer
Role: STUDY_CHAIR
Locations
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UCSD Treatment Ctr
San Diego, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
North Shore Univ Hosp
Great Neck, New York, United States
Columbia Univ Babies' Hosp
New York, New York, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Countries
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References
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Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)
Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.
Other Identifiers
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D0172g
Identifier Type: -
Identifier Source: secondary_id
ACTG 139
Identifier Type: -
Identifier Source: org_study_id