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Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children Clinical research trials and Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children. Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children clinical trial. Test subjects typically receive the most effective healthcare possible for their Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children  Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective. HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.
Details: Since CD4 is the high-affinity receptor for HIV-1, molecules such as CD4-IgG2, which incorporate the gp120 binding region of CD4, have the potential to bind and neutralize all strains of the virus. [AS PER AMENDMENT 4/25/00: Study results have demonstrated that the product is safe in children, well tolerated, and may have antiviral properties. With these encouraging results in hand, an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I.] The study is conducted in two parts. In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels. A minimum of 3 patients are treated at a given dose level. If none of these 3 patients experience Grade 3 or 4 toxicity, patients are escalated to the next dose level. If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities, escalation stops and the prior dose (if any) is considered the maximum tolerated dose (MTD). If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities, 3 additional patients are treated at this dose level. If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity, escalation stops. If none of these 3 additional patients has Grade 3 or 4 toxicity, patients are escalated to the next dose level. Part 2 provides additional data on the safety, toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses. Patients receive the highest safe dose (MTD) as established in Part 1. Treatment is given intravenously once weekly at Weeks 0, 1, 2, and 3. If insufficient activity is seen at this dose level, 6 additional patients will be enrolled at a higher dose level. Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2. If any patient experiences a life-threatening condition due to CD4-IgG2, the study will stop. [AS PER AMENDMENT 4/25/00: Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0, 1, 2 and 3. Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0, 1, and 2; and pre-dose, 1 hour, 24 hours, and Days 3, 7, and 14 after the dose are administered at Week 3. An overnight stay in the hospital is recommended for the first 24 hours. At Weeks 0, 1, 2, and 3, virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG. Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II.]
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 2 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are HIV-positive. - Are 2-12 years old and have consent of parent or legal guardian. - Have HIV levels of 10,000 copies/ml or more on at least 2 occasions and 30 days apart (Part 2 only). - Have been on stable, unchanged anti-HIV therapy for 3 months before study entry. Exclusion Criteria Children will not be eligible for this study if they: - Have an active opportunistic (HIV-related) infection. - Are pregnant. - Are taking certain medications. - Have received any vaccinations within 30 days prior to study entry. - Have a heart problem that would affect their ability to take part in the study. (This study has been changed. The original version didn't mention heart problems.)
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
WilliamShearer, Study Chair,
Children's Hosp of Oakland *No longer recruiting*
Oakland, California, 946091809
United States
No longer recruiting
UCSF / Moffitt Hosp - Pediatric *Recruiting*
San Francisco, California, 941430105
United States
Recruiting Debbie Trevithick 415-476-6480
Children's National Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Veronica Amos 202-884-2837
Univ of Florida Health Science Ctr / Pediatrics *No longer recruiting*
Jacksonville, Florida, 32209
United States
No longer recruiting
Children's Hosp of Michigan *No longer recruiting*
Detroit, Michigan, 48201
United States
No longer recruiting
Long Beach Memorial (Pediatric) *Recruiting*
Long Beach, California, 90801
United States
Recruiting Zane O'Keefe 310-206-6369
UCLA Medical Center (Pediatric) *Recruiting*
Los Angeles, California, 90090-1752
United States
Recruiting Maryanne Dillon 310-825-9660
Children's Hosp of Orange County *No longer recruiting*
Orange, California, 92868
United States
No longer recruiting
Children's Hosp of Philadelphia *No longer recruiting*
Philadelphia, Pennsylvania, 191044318
United States
No longer recruiting
Children's Hosp of Los Angeles/UCLA Med Ctr *Recruiting*
Los Angeles, California, 900276016
United States
Recruiting Zane O'Keefe 310-206-6369
Texas Children's Hosp / Baylor Univ *Recruiting*
Houston, Texas, 77030
United States
Recruiting Kathryn Owl 832-824-2583
Schneider Children's Hosp *No longer recruiting*
New Hyde Park, New York, 11040
United States
No longer recruiting
Additional Information:
Study ID Numbers: ACTG 351; PACTG 351
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000876
Other Hiv Infections Studies:
1. A Study of Two Forms of Pentamidine in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
2. Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
3. A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
4. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
5. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
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