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A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group 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 II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group Clinical research trials and A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group 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 II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group. A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group 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 II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group clinical trial. Human subjects often get the best healthcare available for their A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group 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 II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
For Condition: HIV Infections,Measles
Status: No longer recruiting
Sponsor(s): Merck , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months. Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Details: Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system. Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 6 Months/7 Months
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Positive or negative HIV blood test. - Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria. - No history of opportunistic infection. - No known exposure to measles within 14 days prior to study entry. - CD4+ lymphocyte count >= 750 cells/mm3 or more than 15% at 6 months of age. - Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements. - Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics. NOTE: - Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted. NOTE: - Patients must be located in a geographical area where measles immunization at 12 months is standard of care. Recommended: - Childhood immunizations other than measles according to current guidelines. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Intercurrent illness and/or fever for 7 days. - Known sensitivity or allergy to neomycin or eggs. Concurrent Medication: Excluded: - IVIG. - Uninterrupted or anticipated steroid therapy (>= 2 mg/kg/day) for more than 2 weeks duration. Patients with the prior condition are excluded: - Platelet count < 50,000/mm3 at any time prior to study entry. Prior Medication: Excluded: - Any IgG preparation within the past 6 months.
Total Enrollment: 270
Location and Contact Information:
Overall Study Official:
ChandwaniS, Study Chair,
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
AIDS Clinical Research Ctr / UCLA Med Ctr
Los Angeles, California, 900951793
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Westchester Hosp
Valhalla, New York, 10595
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: ACTG 225;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000815
Other Measles Studies:
1. Treating Genital Herpes to Decrease Risk of HIV Acquisition
2. The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients with and without Symptoms of Infection
3. A Study of Megestrol Acetate in HIV-Infected Children
4. Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People
5. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
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A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
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