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Home > "A" Clinical Trials Conditions > A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease  A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.
Details: The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance. In Stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddI) plus AZT plus nevirapine (NVP); ddI plus AZT; and ddI plus NVP. After 12 weeks of treatment, the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pg/ml AND fewer than two patients experience grade 4 rash. Patients in Stage 1 continue treatment for an additional 36 weeks. In Stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. Stage 2 patients receive treatment for at least 48 weeks. AS PER AMENDMENT 02/12/97: As of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). Patients will be unblinded on or about 5/23/97.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 6 Months/20 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Erythropoietin. Concurrent Treatment: Allowed: - Transfusion. Patients must have: - Progressive HIV disease. - At least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Active malignancy requiring chemotherapy. - Currently receiving therapy in an ACTG primary therapy or salvage protocol who have NOT met an endpoint on that study. - Known intolerance (other than hematologic) or toxicity to ddI, AZT, or NVP at the doses used in this study. Concurrent Medication: Excluded (unless exemption made by study chair): - Oral anticoagulants (warfarin, dicumarol). - Oral contraceptives. - Digitalis glycosides. - Phenytoin. - Theophylline. Patients with the following prior conditions are excluded: - History of clinical pancreatitis. - History of grade 2 or worse peripheral neuropathy. Prior Treatment: Excluded: - Acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.
Total Enrollment: 390
Location and Contact Information:
Overall Study Official:
BurchettS, Study Chair,
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
West Central Ohio Hemophilia Ctr / Children's Med Ctr
Dayton, Ohio, 454041815
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Yale Univ Med School
New Haven, Connecticut, 06504
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Univ of Pittsburgh Med School / Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Bronx Municipal Hosp Ctr / Bronx Lebanon Hosp Ctr
Bronx, New York, 10461
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Additional Information:
Study ID Numbers: ACTG 245;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000814
Other Hiv Infections Studies:
1. A Study of MKC-442 in HIV-Positive Patients
2. A Study of HIV-Disease Development in Aging
3. A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects
4. A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-avium Complex (MAC) Bacteremia in Patients With AIDS
5. A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents with Advanced HIV Disease
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