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Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs Clinical research trials and Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs. Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs clinical trial. Subjects frequently obtain the most expert healthcare possible for their Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs  Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs
Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs
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 look at long-term safety and effectiveness of emtricitabine (FTC), efavirenz (EFV), and didanosine (ddI) taken together once daily in HIV-infected pediatric patients who have taken few or no anti-HIV drugs. Treatment of HIV-infected patients involves combining drugs from different groups of anti-HIV drugs. At present, the preferred combination is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children this treatment may be too complicated or the drugs too difficult to take by mouth. So it is necessary to find other combinations that are effective and easy to take. A study in adults has shown that FTC and ddI (NRTIs) taken once daily together with EFV, a nonnucleoside reverse transcriptase inhibitor (NNRTI), is effective and well tolerated. This study will look at the FTC/EFV/ddI combination in children.
Details: The current most recommended management of HIV-infected pediatric patients and adults dictates the use of combination therapies, generally consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). However, available treatment options for pediatric patients are limited. Such regimens are complicated and few PIs are available in formulations appropriate for young pediatric patients. Therefore, the development of potent combination regimens with proven efficacy but less complicated dosing schedules and/or alternative drugs to PIs, such as nonnucleoside reverse transcriptase inhibitors (NNRTIs), is critical to improving the outcome for HIV-infected pediatric patients. A pilot study of FTC and ddI (NRTIs) in combination with EFV (NNRTI) as a once-daily dosage regimen in treatment-naive HIV-infected adults concluded that the FTC/EFV/ddI combination is potent and well tolerated. This regimen deserves further evaluation in treatment-naive pediatric patients. Patients are stratified based on their age at study entry: Group 1: 90 days to less than 3 years of age. Group 2: 3 years to 12 years of age, inclusive. Group 3: 13 years to 21 years of age, inclusive. Patients also are stratified for data analysis purposes by previous antiretroviral exposure: absolutely naive or antiretroviral-exposed. Patients receive FTC, EFV, and ddI together once daily. Intensive pharmacokinetic (PK) studies are done at Week 2 of treatment to determine if dose adjustments are required for any of the drugs and as needed if virologic failure is determined. PK studies are repeated 4 weeks after adjustments in therapy. Tests to monitor virology, immunology, hematology, chemistries, liver function, and pregnancy markers are performed periodically.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 90 Days/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 90 days to 21 years old. - Have never taken anti-HIV drugs, have gotten no more than 56 days of drugs to prevent HIV infection at birth, or have gotten less than 7 total days of drugs as a treatment. - Have viral load (level of HIV in the blood) of 5000 copies/ml or more. - Are HIV-positive. - Are able to take drugs by mouth. - Have consent of a parent or guardian if under 18 years old. - Agree to use 2 methods of birth control (at least 1 barrier method), if female, sexually active, and able to have children. - Have a negative pregnancy test within 72 hours before the first dose of study drug, if female and able to have children. Exclusion Criteria Patients will not be eligible for this study if they: - Are allergic to FTC, EFV, or ddI, or any other ingredients in the products. - Have kidney disease. - Are positive for hepatitis B or C. - Have an AIDS-related or other infection needing drugs at study entry. - Have taken anti-cancer drugs within 1 year before the screening visit. - Are pregnant or breast-feeding. - Have a serious medical event within 21 days before the screening visit. - Are receiving drugs to treat tuberculosis. - Have or have had pancreatitis (inflammation of the pancreas). - Take astemizole, cisapride, ergot alkaloid derivatives, midazolam, triazolam, rifampin, zolpidem, systemic steroids, growth hormone, cytokines, or St. John's wort. Short courses of steroids (less than 14 days) for asthma are allowed. - Take anti-HIV drugs other than those included in this study. - Take any investigational drugs. - Have or have had significant peripheral neuropathy (a disease of the nerves). - Have difficulty with food or severe chronic diarrhea within 30 days before study entry. - Are unable to eat at least 1 meal per day or to feed at least 3 times per day (for infants) because of chronic nausea, vomiting, swallowing problems, or stomach upset.
Total Enrollment: 42
Location and Contact Information:
Overall Study Official:
MobeenRathore, Study Chair,
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Nagamah Deygoo 212-263-6426
Univ of Miami (Pediatric) *Recruiting*
Miami, Florida, 33161
United States
Recruiting Patricia Bryan 305-243-2154
Tulan Univ., Charity Hosp of New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Margaret Cowie 504-586-3804
San Juan City Hosp *Recruiting*
San Juan, , 009367344
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
Los Angeles County - USC Med Ctr *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2342
Univ of Massachusetts Med School *Recruiting*
Worcester, Massachusetts, 016550001
United States
Recruiting Donna Christian 508-856-1692
Metropolitan Hosp Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
SUNY Health Sciences Ctr at Syracuse / Pediatrics *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Kathie Contello 315-464-6331
Howard Univ Hosp *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Patricia Yu 202-865-4578
State Univ of New York at Stony Brook *Recruiting*
Stony Brook, New York, 117948111
United States
Recruiting Michell Davi 516-444-1313
Connecticut Childrens Med Ctr (Pediatric) *Recruiting*
Farmington, Connecticut, 06030-3805
United States
Recruiting Gail Karas 860-679-2320
Univ of Florida Health Science Ctr / Pediatrics *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Michelle Eagle 904-244-5331
Univ of Puerto Rico / Univ Children's Hosp AIDS *Recruiting*
San Juan, , 009365067
Puerto Rico
Recruiting Sylvia Nieves 787-759-9595
Texas Children's Hosp / Baylor Univ *Recruiting*
Houston, Texas, 77030
United States
Recruiting Kathryn Owl 832-824-2583
Med Univ of South Carolina *No longer recruiting*
Charleston, South Carolina, 294253312
United States
No longer recruiting
Chicago Children's Memorial Hosp *Recruiting*
Chicago, Illinois, 606143394
United States
Recruiting Debbie Fonken-Cloutier 773-880-3669
Children's Hosp of Denver *Recruiting*
Denver, Colorado, 802181088
United States
Recruiting Carol Salbenblatt 303-861-6751
St. Louis Children's Hosp *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Laura Stiffler 314-454-2576
Univ of Mississippi Med Ctr *No longer recruiting*
Jackson, Mississippi, 39213
United States
No longer recruiting
Saint Jude Children's Research Hosp of Memphis *Recruiting*
Memphis, Tennessee, 381052794
United States
Recruiting Jill Utech 901-495-3490
Univ of Chicago Children's Hosp *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Pamela Lofton 773-702-3853
UCSF / Moffitt Hosp - Pediatric *Recruiting*
San Francisco, California, 941430105
United States
Recruiting Debbie Trevithick 415-476-6480
Columbia Presbyterian Med Ctr *No longer recruiting*
New York City, New York, 10032
United States
No longer recruiting
Duke Univ Med Ctr *Recruiting*
Durham, North Carolina, 277103499
United States
Recruiting John Swetnam 919-684-6335
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
Additional Information:
Study ID Numbers: ACTG P1021; PACTG P1021
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016718
Other Hiv Infections Studies:
1. Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
2. A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments
3. A Study of 141W94 Used Alone or in Combination with Zidovudine Plus 3TC in HIV-Infected Patients
4. A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
5. Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Patients Following Failure with Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
Related Studies:
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Safety and Effectiveness of Emtricitabine Taken Once Daily with Efavirenz and Didanosine in HIV-Infected Children Who Have Taken Few or No Anti-HIV Drugs
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