|
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Clinical research trials and Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children. Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children clinical trial. Test subjects typically receive the most effective healthcare possible for their Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children  Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),Pediatric European Network for Treatment of AIDS
Synopsis: Little is known about what treatment combinations are best for HIV infected children. This study will examine the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study will enroll children who have not previously taken anti-HIV medication. Some children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
Details: Antiretroviral therapy in children aims to prolong clinical and immunologic health. Currently, there are no data defining a particular highly active antiretroviral therapy (HAART) strategy as the optimal first-line therapy for children. This study will evaluate the long-term efficacy of two HAART regimens used as initial therapy: 1) two nucleoside reverse transcriptase inhibitors (NRTIs) plus a protease inhibitor (PI), and 2) two NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI). It will also evaluate different strategies for switching therapy when the initial regimen fails. The long-term nature of this study should clarify whether early switching of therapy improves immunologic and virologic outcomes, or results in a more rapid exhaustion of treatment options. The study will be conducted in the United States and in Europe. Participants in this study will have a CD4 cell count and viral load test during a screening visit. Participants will have an entry visit that will include blood and urine tests, a neurologic exam, a chest X-ray, and a behavioral and learning development exam. Participants will then be randomly assigned to one of four groups: Groups 1A and 1B will receive two NRTIs plus a PI; Groups 2A and 2B will receive two NRTIs plus an NNRTI. The medications allowed in the study are: abacavir succinate, didanosine, lamivudine, lamivudine/zidovudine, stavudine, zalcitabine, and zidovudine (NRTIs); efavirenz and nevirapine (NNRTIs); and amprenavir, indinavir, lopinavir/ritonavir, nelfinavir, saquinavir, and ritonavir (PIs). For participants whose initial regimen fails, a second-line therapy is strongly encouraged. In this second-line therapy, participants who initially took NRTIs with a PI will switch to NRTIs and an NNRTI. Participants who initially took NRTIs and an NNRTI will switch to NRTIs and a PI. The timing of the switch will be based on the participant’s group: Groups 1A and 2A will switch to second-line treatment when viral load is 1000 copies/ml or greater; Groups 1B and 2B will switch to second-line treatment when viral load is 30,000 copies/ml or greater. Participants will have study visits at Weeks 2, 4, 8, 12, 16, 24, and every 12 weeks thereafter until the drug regimen is switched to second-line treatment. Participants will then have a re-entry visit and the schedule of visits will restart. Participants will be in the study between 4 and 8 years, depending on when they enroll. Participants in the European portion of the study may be asked to enroll in a substudy to observe the development and progression of lipodystrophy syndrome.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: /18 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Older than 30 days and younger than 18 years of age (may enroll up to the day before their 18th birthday) - HIV infected - Not previously on HAART or received anti-HIV drugs for less than 56 consecutive days after birth to prevent mother-to-infant transmission, and/or no more than two doses of nevirapine - Acceptable methods of contraception Exclusion Criteria - Grade 3 or 4 clinical or laboratory toxicity as defined by the study - Active opportunistic infection and/or a serious bacterial infection at the time of study entry - Pancreas, nervous system, blood, liver, or kidney problems that make it impossible to take study medications - Taking any medication that cannot be combined with the study medications - Received therapy for cancer - Pregnant or breast-feeding
Total Enrollment: 256
Location and Contact Information:
Overall Study Official:
AnnMelvin, Study Chair, Children's Hospital and Medical Center, Seattle, WA
UCSD Mother, Child & Adolescent HIV Programs
San Diego, California, 92103
United States
Linda Proctor 619-543-8080
Harlem Hosp
New York City, New York, 10037
United States
Delia Calo 718-270-4190
Children's Hospital of Boston
Boston, Massachusetts, 02115
United States
Kirk Bertelsen 617-355-8198
North Broward Hosp District
Ft. Lauderdale, Florida, 33316
United States
Amy Inman 954-728-1050
Univ of Florida, Gainsville
Gainesville, Florida, 32610-0296
United States
Carol Delany 352-846-3598
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Kathryn Owl 832-824-2583
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Susan Marks 562-595-0812
Connecticut Childrens Med Ctr (Pediatric)
Farmington, Connecticut, 06030-3805
United States
Gail Karas 860-679-2320
Univ of Puerto Rico, U. Childrens Hosp AIDS
San Juan, , 00936-5067
Puerto Rico
Sylvia Davila 787-759-9595
Univ of South Florida
St. Petersburg, Florida, 33701
United States
Carolyn Graisbery 727-892-4184
Duke Univ (Pediatric)
Durham, North Carolina, 27705
United States
John Swetnam 919-416-3447
Baylor (Texas Childrens Hosp)(Pediatric)
Houston, Texas, 77030
United States
Kathryn Owl 832-824-2583
Children's Hosp of LA (Pediatric)
Los Angeles, California, 90054
United States
Theresa Dunaway 323-669-4537
State Univ of New York at Stony Brook
Stony Brook, New York, 11794-8111
United States
Michell Davi 516-444-1313
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37232
United States
Peggy Bender 615-322-2250
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 38105-2794
United States
Laura Utech 901-495-3490
San Juan City Hosp
San Juan, ,
Puerto Rico
Maria Pilar Thurin 787-765-4186
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 70112-2699
United States
Margaret Cowie 504-586-3804
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Maureen Famiglietti 312-464-6331
Oregon Health and Science University
Portland, Oregon, 97239
United States
Roger Croteau 503-494-2427
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Patricia Yu 202-865-4578
The Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Marie Donahue 212-305-7222
Lowell Community Health Center
Lawrence, Massachusetts, 01841-2884
United States
Donna Picard 978-689-6731
Univ of Rochester Med Ctr
Rochester, New York, 14642-0001
United States
Barbra Murante 585-275-1549
Univ of Chicago Childrens Hosp
Chicago, Illinois, 60637
United States
Pamela Lofton 773-702-3853
Lawrence Family Health Center
Lawrence, Massachusetts, 01841-2884
United States
Donna Picard 978-689-6731
Children's Hosp of Oakland
Oakland, California, 94609-1809
United States
Teresa Courville 510-428-3885
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 07103-2714
United States
Mary Hoyt 973-972-3118
Univ of Miami (Pediatric)
Miami, Florida, 33136
United States
Patricia Bryan 305-243-4447
Chicago Children's Memorial Hosp
Chicago, Illinois, 60614-3394
United States
Debbie Fonken-Cloutier 773-880-3669
Additional Information:
Study ID Numbers: PENTA 9/PACTG 390; PENPACT-1B
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039741
Other Hiv Infections Studies:
1. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3
2. Safety and Effectiveness of a Four-Drug Combination Treatment in HIV-infected Subjects Failing Therapy with Antiretroviral Regimens
3. A Study of Isoprinosine in Patients with Severe AIDS
4. Increasing HAART-Induced Immune Restoration with Cyclosporine
5. A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children
|
|
|
|
|
|
|
|
