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Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents Clinical research trials and Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents. Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents clinical trial. Participants oftentimes recieve the finest healthcare available for their Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents  Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
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: The purpose of this study is to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (also known as BMS-232632 or ReyatazTM), with or without a low-dose boost of the PI ritonavir, when taken with other anti-HIV drugs in HIV-infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV-positive children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. Atazanavir may be a better option for these patients because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of ritonavir as a boosting agent for atazanavir may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study will try to find safe and tolerable doses of atazanavir with or without low-dose ritonavir boost in infants, children, and adolescents. For this study, patients will be enrolled in the U.S. and South Africa.
Details: Advancements in HAARTs for HIV-infected children and adolescents are hindered by patient nonadherence. The availability of a powder formulation and the once-daily dosing schedule make atazanavir an attractive agent for improved adherence in pediatric treatment regimens. This study is designed to provide pharmacokinetic data to guide dosing recommendations for atazanavir, when given concurrently with or without low-dose ritonavir boost, in infants, children, and adolescents. During the study, the safety and tolerance of atazanavir (with or without low-dose ritonavir) will be closely monitored, and virologic efficacy data will be obtained. There are two parts to this study. Step I is open in the U.S. and South Africa, and is further divided into two groups, Parts A and B. Part A participants will receive atazanavir only and part B participants will receive atazanavir with low-dose ritonavir boost. Patients receive atazanavir once a day with 2 other antiretroviral drugs (not provided by the study), and in part B patients only (Groups 5 to 8), atazanavir is given with a low dose of ritonavir. Patients are placed into 1 of 8 groups (Groups 1 to 4 for part A; Groups 5 to 8 for part B) with respect to age and study drug formulation. Patients in Groups 1 and 5 are infants age 3 months and 1 day (91 days) up to 2 years (less than or exactly 730 days) and take atazanavir in powder form. Patients in Groups 2, 3, 6, and 7 are children age 2 years and 1 day (731 days) or more up to 13 years. Groups 2 and 6 receive atazanavir in powder form, while Groups 3 and 7 receive the capsule form. Patients in Groups 4 and 8 are adolescents age 13 years and 1 day up to 21 years (not including the 22nd birthday) and take atazanavir in capsule form. For each group, enrollment starts with 5 patients per group, with all patients evaluated for pharmacokinetic and safety criteria, adjusting the dose until one is found that passes both sets of criteria. Then 5 additional patients are enrolled, with enrollment continuing for each group once all patients within that group meet the pharmacokinetics criteria. Clinic visits are every 4 weeks through Week 48, then every 8 weeks until the last patient to enroll in the study has reached Week 96 of his/her treatment. At every visit, patients undergo a complete medical history and physical exam, cardiac conduction evaluation, and urine and blood collection. Patients of childbearing age have a pregnancy test performed at each visit. Step II is open only to South African participants of Step I who have responded to treatment by the end of Step I. All such participants will be given atazanavir in capsule form at the same dose they received at the end of Step I, as well as the other antiretrovirals they were receiving during the course of Step I. Step II will continue until atazanavir is approved in South Africa and readily available by individual prescription and participants will have a study visit every 12 months.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 3 Months/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria [Note: Groups 1 and 2 are no longer open to accrual.] - Have HIV infection. - Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more. - Are able to take 2 NRTIs that they have never taken before. - Take a test showing they can respond to atazanavir. - Are able and willing to swallow the study drugs. - Are 3 months and 1 day (91 days) to 21 years old. - Agree to practice abstinence or use effective barrier method of birth control if they are able to become pregnant. - Have signed consent of parent or guardian if under 18 years of age. - Are willing to undergo complete cardiac conduction evaluation at screening. - For Step II, are South African participants from Step I that are virologically successful by Week 96 of the last study patient enrolled in their respective part of Step I. Exclusion Criteria - Have hepatitis. - Have a serious infection that requires treatment at the time of study entry. - Are allergic to atazanavir. - Are receiving chemotherapy for cancer. - Have any serious conditions (other than HIV infection) at study entry that might affect the results of the study. - Are pregnant or breast-feeding. - Show toxicity at study entry. - Are receiving certain drugs or treatments. - Are receiving pentamidine (by vein) for Pneumocystis carinii pneumonia within 3 months of study entry; ongoing monthly treatment with orally-inhaled pentamidine for prophylaxis is not excluded. - Have a history of significant cardiac abnormalities or dysfunction. - For Part II, virologic failure or the investigator deems discontinuation appropriate based on toxicity/tolerability.
Total Enrollment: 152
Location and Contact Information:
Overall Study Official:
RichardRutstein, Study Chair, Children's Hospital of Philadelphia
Children's Hosp of Washington DC *No longer recruiting*
Washington D.C., District of Columbia, 200102916
United States
No longer recruiting
UMDNJ - Robert Wood Johnson Med School / Pediatrics *No longer recruiting*
New Brunswick, New Jersey, 089030019
United States
No longer recruiting
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33161
United States
Recruiting Charlotte Goldberg 305-243-4447
The Med Ctr *Recruiting*
Columbus, Georgia, 31901
United States
Recruiting Dawn Barnes 706-571-1449
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Mary Hoyt 973-972-3118
Schneider Children's Hosp *No longer recruiting*
New Hyde Park, New York, 11040
United States
No longer recruiting
Univ of Florida Health Science Ctr / Pediatrics *No longer recruiting*
Jacksonville, Florida, 32209
United States
No longer recruiting
Children's Hosp of the King's Daughters *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Donna Sandifer 757-668-7238
Univ of Rochester Med Ctr *No longer recruiting*
Rochester, New York, 146420001
United States
No longer recruiting
UCLA Med Ctr / Pediatric *Recruiting*
Los Angeles, California, 900951752
United States
Recruiting Maryanne Dillon 310-206-6369
State Univ of New York at Stony Brook *Recruiting*
Stony Brook, New York, 117948111
United States
Recruiting Michell Davi 516-444-1313
Univ of Alabama at Birmingham - Pediatric *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Terry Byars 205-558-2328
Children's Hosp of Boston *Recruiting*
Boston, Massachusetts, 021155724
United States
Recruiting Kirk Bertelsen 617-355-8198
Johns Hopkins Hosp - Pediatric *Recruiting*
Baltimore, Maryland, 212874933
United States
Recruiting Suzanne Marvin 410-955-9749
Duke Univ Med Ctr *No longer recruiting*
Durham, North Carolina, 277103499
United States
No longer recruiting
Children's Hosp of Oakland *Recruiting*
Oakland, California, 946091809
United States
Recruiting Teresa Courville 510-428-3885
Univ of Massachusetts Med School *Recruiting*
Worcester, Massachusetts, 016550001
United States
Recruiting Donna Christian 508-856-1692
The Columbia Presbyterian Med Ctr *Recruiting*
New York City, New York, 10032
United States
Recruiting Marie Donahue 212-305-7222
Med Univ of South Carolina *No longer recruiting*
Charleston, South Carolina, 294253312
United States
No longer recruiting
Univ of Medicine & Dentistry of New Jersey / Univ Hosp *Recruiting*
Newark, New Jersey, 071032714
United States
Recruiting Mary Hoyt 973-972-3118
SUNY Health Sciences Ctr at Syracuse / Pediatrics *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Kathie Contello 315-464-6331
Children's Hosp of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 191044318
United States
Recruiting Carol Vincent 215-590-2262
Children's Hosp of Denver *Recruiting*
Denver, Colorado, 802181088
United States
Recruiting Carol Salbenblatt 303-861-6751
Univ of Mississippi Med Ctr *No longer recruiting*
Jackson, Mississippi, 39213
United States
No longer recruiting
Ramon Ruiz Arnau Univ Hosp / Pediatrics *No longer recruiting*
Bayamon, , 00956
Puerto Rico
No longer recruiting
Univ of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Mary Caffery 619-543-8080
Cook County Hosp *No longer recruiting*
Chicago, Illinois, 60612
United States
No longer recruiting
Metropolitan Hosp Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Bronx Municipal Hosp Ctr/Jacobi Med Ctr *Recruiting*
Bronx, New York, 10461
United States
Recruiting Wanda Biernick 718-918-4516
Long Beach Memorial (Pediatric) *Recruiting*
Long Beach, California, 90801
United States
Recruiting Lisa Melton 562-595-0812
Bronx Lebanon Hosp Ctr *Recruiting*
Bronx, New York, 10457
United States
Recruiting Shailaja Kancherla
Univ of Puerto Rico / Univ Children's Hosp AIDS *Recruiting*
San Juan, , 009365067
Puerto Rico
Recruiting Carmen Rivera 787-759-9595
Harlem Hosp Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Delia Calo 212-939-4045
Los Angeles County - USC Med Ctr *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2342
UCSF / Moffitt Hosp - Pediatric *Recruiting*
San Francisco, California, 941430105
United States
Recruiting Debbie Trevithick 415-476-6480
Children's Hospital & Medical Center / Seattle ACTU *No longer recruiting*
Seattle, Washington, 981050371
United States
No longer recruiting
Montefiore Medical / AECOM *Recruiting*
Bronx, New York, 19461
United States
Recruiting Gayle Kreinik 718-430-2940
Saint Jude Children's Research Hosp of Memphis *Recruiting*
Memphis, Tennessee, 381052794
United States
Recruiting Micki Roy 901-495-2004
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Nagamah Deygoo 212-263-6426
Saint Christopher's Hosp for Children *Recruiting*
Philadelphia, Pennsylvania, 191341095
United States
Recruiting Roslynn Buie 215-427-8443
UCLA Med Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Maryanne Dillon 310-206-6369
Tulane Univ / Charity Hosp of New Orleans *Recruiting*
New Orleans, Louisiana, 701122699
United States
Recruiting Margaret Cowie 504-586-3804
Texas Children's Hosp / Baylor Univ *Recruiting*
Houston, Texas, 77030
United States
Recruiting Kathryn Owl 832-824-2583
Howard Univ Hosp *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Helga Finke 202-865-1248
Baystate Med Ctr of Springfield *Recruiting*
Springfield, Massachusetts, 01199
United States
Recruiting MariPat Toye 413-794-5399
Additional Information:
Study ID Numbers: ACTG P1020-A; PACTG P1020-A
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006604
Other Hiv Infections Studies:
1. Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant
2. A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection
3. Depot Disulfiram for AIDS and ARC
4. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
5. A Study of Patients Who Recently Have Been Infected with HIV
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Atazanavir Used in Combination with Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents
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