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Home > "A" Clinical Trials Conditions > A Study to Compare Two Different Anti-HIV Drug Regimens  A Study to Compare Two Different Anti-HIV Drug Regimens
A Study to Compare Two Different Anti-HIV Drug Regimens
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood. The anti-HIV drugs used in this study are 2 protease inhibitors (nelfinavir and ritonavir), 2 nucleoside reverse transcriptase inhibitors (stavudine and didanosine), and 1 nonnucleoside reverse transcriptase inhibitor (nevirapine). These drug combinations have been previously studied in adults, but there is limited information on how well they work in HIV-infected children. It is important to develop drug combinations which are effective at suppressing the HIV virus in children.
Details: The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children. Patients are stratified by prior antiretroviral treatment (zidovudine [ZDV]/lamivudine [3TC] versus d4T/other treatment) and by age (under 24 months versus 24 months and older). Patients are then randomized to 1 of 4 treatment groups. Arm A1: ddI/NFV/RTV (for prior ZDV/3TC-treated patients). Arm A2: ddI/NFV/RTV (for prior d4T/other-treated patients). Arm B1: d4T/NFV/NVP (for prior ZDV/3TC-treated patients). Arm B2: d4T/NFV/NVP (for prior d4T/other-treated patients). Treatment is administered for 48 weeks. At Weeks 2, 4, and then every 4 weeks thereafter, patients undergo physical examinations, and blood samples are drawn to measure viral load. [AS PER AMENDMENT 4/27/00: Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks. While on the treatment extension, patients must continue their current schedule for study drug administration and completion of study visits. Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension. Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study.]
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 4 Months/21 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are between 4 months and 21 years of age (consent of parent or guardian required if under 18). - Are HIV-positive. - Have a viral level of at least 4,000 copies/ml. - Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months. - Have received the same continuous antiretroviral therapy for the past 16 weeks. Exclusion Criteria Patients will not be eligible for this study if they: - Have an active opportunistic and/or serious bacterial infection. - Have been diagnosed with a malignancy. - Have received prior treatment with certain antiretroviral medications. - Are pregnant or breast-feeding.
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
AndrewWiznia, Study Chair,
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of South Alabama
Mobile, Alabama, 36604
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Earl K Long Early Intervention Clinic
New Orleans, Louisiana, 70112
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
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Additional Information:
Study ID Numbers: ACTG 403; P1001S (substudy),P1004S (substudy),PACTG 403
Study Start Date: February 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000924
Other Hiv Infections Studies:
1. Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
2. An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients
3. A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination with Soluble Recombinant Envelope Vaccine (VaxSyn)
4. The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-dideoxyinosine or 2',3'-dideoxycytidine in Patients with Human Immunodeficiency Virus Disease
5. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Babies
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
A Study to Compare Two Different Anti-HIV Drug Regimens
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