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Home > "C" Clinical Trials Conditions > Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children  Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children
Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Details: In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken. Eligible subjects receiving d4T will be assigned in an open manner to Arm 1, and subjects who have been receiving zidovudine (AZT) will be assigned in a randomized, double blind manner to Arms 2 and 3. Each subject will receive study drug for 48 weeks as follows: Arm 1 - d4T plus ddI, Arm 2 - d4T alone, Arm 3 - d4T plus ddI.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 6 Months/10 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must: - Be on-study, on-treatment in ACTG 240, or receiving AZT monotherapy by prescription for at least 6 months immediately preceding enrollment. - Have laboratory evidence of HIV-1 infection < 18 months - 2 positive viral tests >= 18 months - 2 positive viral tests or 2 or more positive tests for HIV antibody - Have parent or legal guardian willing to sign a consent. Prior Medication: Required: - On-study, on-treatment in ACTG 240 (D4T or AZT) or receiving AZT monotherapy by prescription for at least six months immediately preceding this trial. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Intractable diarrhea or vomiting. - Current clinical or laboratory Grade 3 or worse toxicities. Concurrent Medication: Excluded: - Concurrent use of antiretroviral agents other than those provided by the study, immunomodulators (other than IVIG or corticosteroids), or other investigational drugs except for those in ACTG 254 and ACTG 219. - Chemotherapy for active malignancy. Patients with any of the following prior conditions are excluded: - Reached an ACTG 240 defined endpoint, or are permanently off ACTG 240 study treatment. - Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously. - Subjects who have had chemotherapy for active malignancy. Prior Medication: Excluded: - Prescription AZT recipients may not have received > 6 weeks of d4T or ddI previously.
Total Enrollment: 198
Location and Contact Information:
Overall Study Official:
KlineM, Study Chair,
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
Los Angeles, California, 900593019
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
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
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Additional Information:
Study ID Numbers: ACTG 327;
Study Start Date:
Record last reviewed: April 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000851
Other Hiv Infections Studies:
1. A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
2. A Study of CI-1012 in HIV-Infected Patients
3. Effectiveness of Anti-HIV Drugs in Patients Who Have Not Received Previous Anti-HIV Drugs During Different Stages of HIV Infection
4. Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination with Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
5. A Study of Azidothymidine (AZT) in the Treatment of HIV Infection in Patients Receiving a Bone Marrow Transplant
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Brooklyn Clinical Trials
Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children
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