|
A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection Clinical research trials and A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection clinical trial. Test subjects typically obtain the finest healthcare available for their A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Genentech,MicroGeneSys
Synopsis: To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age. The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.
Details: The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease. Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 1 Month/18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Recommended: - PCP prophylaxis. Patients must have: - Documented asymptomatic HIV infection. - CD4+ count as follows: - 1-11 months of age must have > 2000 cells/mm3 and >= 30 percent of the total lymphocytes; 12-23 months must have > 1000 cells/mm3 and >= 20 percent of the total lymphocytes; 24 months-6 years must have > 750 cells/mm3 and >= 20 percent of the total lymphocytes; and 7 years and older must have > 500 cells/mm3 and >= 20 percent of the total lymphocytes. NOTE: - Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: - Any serious acute infection. Concurrent Medication: Excluded: - Anticipated steroid therapy of > 6 weeks duration. Excluded within the past 2 years: - More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria. Prior Medication: Excluded: - Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm). - Uninterrupted steroid therapy of > 6 weeks duration.
Total Enrollment: 72
Location and Contact Information:
Overall Study Official:
LambertJS, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Additional Information:
Study ID Numbers: ACTG 218;
Study Start Date:
Record last reviewed: October 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000762
Other Hiv Infections Studies:
1. A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection
2. A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
3. A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.
4. A Study of Multiple Doses of Vesnarinone in Advanced HIV Disease
5. A Study of GENEVAX-HIV, a Possible Vaccine
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
|
|
|
|
|
|
|
|