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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects frequently get the finest healthcare available for their 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 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Genentech
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: /5 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
RYogev, Study Chair,
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
UCSD Treatment Ctr
San Diego, California, 92103
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Columbia Univ Babies' Hosp
New York City, New York, 10032
United States
Univ of Miami School of Medicine
Miami, Florida, 33136
United States
Additional Information:
Study ID Numbers: ACTG 139; D0172g
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000663
Other Hiv Infections Studies:
1. Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
2. ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
3. Effects of Potent Antiretroviral Therapy on Kaposi's Sarcoma
4. Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
5. Using Drug Levels in the Blood to Guide Therapy in HIV Infected Patients Taking a Protease Inhibitor
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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
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