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Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection Clinical research trials and Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection. Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection  Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection
Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
Details: This study examines the antiretroviral activity of ZDV/3TC/NVP in vertically-infected infants and children aged 15 days up to 2 years, and ZDV/3TC/NVP/ABC in vertically-infected infants and children aged 30 days up to 2 years. This study will assess HIV-1 and CD4/CD8 T-cell kinetics, activation, and maturation. It will also test the concept that early (younger than 3 months of age) use of potent, combination antiretroviral therapy will allow the long-term control of viral replication with preservation of normal immune function. [AS PER AMENDMENT 3/11/98: This study will also examine the antiretroviral activity of ZDV/3TC/NVP/NFV in vertically infected infants and children.] This is a 2-part Phase I/II, open-label trial in HIV-infected infants. Part A assesses the triple combination of ZDV, 3TC, and NVP. Four to eight patients are enrolled in each age cohort (Cohort 1: at least 15 days, no more than 3 months; Cohort 2: over 3 months, no more than 2 years). Part B assesses the quadruple combination of ZDV, 3TC, NVP, and ABC. Eight patients are enrolled in each age cohort (Cohort 3: at least 30 days, no more than 3 months; Cohort 4: over 3 months, no more than 2 years). [AS PER AMENDMENT 3/11/98: This study is now a 3-part Phase I/II trial. Parts A and B are as above. Part C will assess the quadruple regimen of d4T, 3TC, NVP and NFV. Up to 8 patients will be enrolled in each age cohort (Cohort 5: at least 15 days, no more than 3 months; Cohort 6: over 3 months, no more than 2 years). If 3 of 4 patients in either cohort of Part B do not achieve plasma RNA less than 1,000 copies/ml after 16 weeks of quadruple therapy, enrollment of patients to that cohort will stop and enrollment of 8 patients to the corresponding cohort in Part C will begin. For Part C, patients whose RNA level is no more than 1,000 copies/ml at Week 16 will remain on assigned treatment until Week 104. If at any time between Weeks 16 and 104 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are greater than 1,000 copies/ml, the patient will discontinue study treatment and be followed every 12 weeks for 1 year.] [AS PER AMENDMENT 4/14/99: The study has been extended for an additional 96 weeks for children with continued suppression of viral replication (RNA less than 400 copies/ml) at Week 104. If at any time between Week 12 or 16 and Week 200 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are above 1,000 copies/ml, the patient will discontinue treatment for best available therapy and be followed every 12 weeks for 1 year following the discontinuation of study treatment.] [AS PER AMENDMENT 9/16/99: An additional cohort (Cohort 7) of 5 to 10 patients has been added. Cohort 7 includes patients between 15 days and 3 months of age. Cohort 7 patients who experience suppression of viral replication at Week 104 are followed through Week 200.]
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: /2 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Children may be eligible for this study if they: - Are 15 days to 2 years old. - Have consent of parent or legal guardian. - Are HIV-positive. Exclusion Criteria Children will not be eligible for this study if they: - Have certain infections which require treatment during the study. - Have received certain medications.
Total Enrollment: 62
Location and Contact Information:
Overall Study Official:
KatherineLuzuriaga, Study Chair,
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, 06106
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Univ TX Galveston Med Branch
Galveston, Texas, 775550835
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
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
Additional Information:
Study ID Numbers: ACTG 356; PACTG 356
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000872
Other Hiv Infections Studies:
1. A Study of HIV in Newly Infected Individuals
2. A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
3. The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-dideoxyinosine or 2',3'-dideoxycytidine in Patients with Human Immunodeficiency Virus Disease
4. The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
5. HIV-Associated Heart Disease
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Treatment with Combinations of Several Antiviral Drugs in Infants and Young Children with HIV Infection
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