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-IgG). 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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: CD4-IgG	Phase I

Further Study Details: 

Expected Total Enrollment:  18

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.

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.

Ages Eligible for Study:  up to  5 Years,  Genders Eligible for Study:  Both

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.

California
      UCSD Treatment Ctr, San Diego,  California,  92103,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
Illinois
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
Louisiana
      Tulane Univ Med School, New Orleans,  Louisiana,  70112,  United States
New York
      North Shore Univ Hosp, Great Neck,  New York,  11021,  United States
      Columbia Univ Babies' Hosp, New York,  New York,  10032,  United States
Texas
      Texas Children's Hosp / Baylor Univ, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

R Yogev,  Study Chair
W Shearer,  Study Chair

Study ID Numbers:  ACTG 139; D0172g
Record last reviewed:  October 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000663
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08