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A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers Clinical research trials and A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers. A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers clinical trial. Human subjects often get the best healthcare available for their A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers  A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
For Condition: HIV Infections,HIV Seronegativity
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Genentech,Biocine
Synopsis: PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants. SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women. Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression.
Details: Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression. Newborns are randomized to one of three different doses of either rgp120/HIV-1MN or rgp120/HIV-1SF2 or their matching placebos. At each dose level, 12 patients receive vaccine and three patients receive placebo. Immunizations are performed at 0, 4, 12, and 20 weeks, and patients are followed until 2 years of age. Three of four patients treated at a given dose level must have received two immunizations without evidence of grade 3 or 4 clinical or laboratory toxicity before dose escalation occurs. Twelve additional patients are treated with the optimal dose of each vaccine at weeks 0, 2, 8, and 20 (An accelerated schedule PER AMENDMENT 3/20/96. Changed from - 0, 4, 8, and 20) accompanied by three additional placebo patients per vaccine. PER AMENDMENT 3/20/96: The optimal dose of rgp120/HIV-1MN is 100 mcg and will be given to the 12 patients and the placebo will be given to 3. The optimal dose of rgp120/HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given to 3. PER 2/3/95 AMENDMENT: After the initial patients are enrolled, 18 additional newborns will be randomized to one of the three dose levels of rgp120/HIV-1MN (with no placebos). PER AMENDMENT 6/5/95: Another group of 18 newborns will be randomized to one of three treatments representing 3 different doses of the Chiron/Biocine vaccine (with no placebos).
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: /3 Days
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretroviral therapy. - Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization. - Routine immunizations if given more than 1 week before or after study vaccine. Patients must be: - > 37 weeks gestation and < 72 hours of age born to HIV-infected women. - NOT born to women who received either passive or active immunotherapy during pregnancy. - NOT breast-fed. - NOT born to women who are hepatitis B surface antigen positive. - Receiving AZT at study entry (except infants enrolled in ACTG 076). NOTE: - Parent or guardian must provide informed consent and be willing to comply with study requirements. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions. Concurrent Medication: Excluded: - Passive or active HIV-specific immunotherapy other than the study candidate vaccines. - Investigational medications.
Total Enrollment: 156
Location and Contact Information:
Overall Study Official:
BorkowskyW, Study Chair,
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 230;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000774
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3. A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women
4. Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2
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A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
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