A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
NCT ID: NCT00001049
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
180 participants
INTERVENTIONAL
1998-06-30
Brief Summary
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PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms.
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.
Detailed Description
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In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended 6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI combination therapy. After pharmacokinetic data are obtained, an additional cohort of patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of age.) Part B patients less than 90 days of age (was less than 180 days of age; amended 6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients continue treatment until 12 months after the last patient on Part B is enrolled. PER AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm, randomized, double-blind study to assess safety, toxicity and tolerability as well as anti-HIV activity of ddI or AZT/ddI.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Zidovudine
Didanosine
Eligibility Criteria
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Inclusion Criteria
Recommended:
* PCP prophylaxis.
Allowed:
* Acetaminophen if not on a continual basis.
NOTE:
* Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution.
Patients must have at least one of the following:
* Documented HIV infection.
* Been born to an HIV-infected woman and receiving AZT.
PER AMENDMENT 4/8/97:
* Number 2 above no longer required with closure of Part A of study.
* Patients must have signed, informed consent of parent or legal guardian.
PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age.
PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age.
NOTE:
* All patients must have been more than 34 weeks gestation at birth.
Prior Medication:
Allowed:
* Prior vaccine therapy.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Pancreatitis.
* Clinically unstable condition.
* Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status.
Concurrent Medication:
Excluded:
* Vaccine therapy.
Patients with the following prior condition are excluded:
* Pancreatitis at any time since birth.
Prior Medication:
Excluded in Part B patients only:
* More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.
1 Day
3 Months
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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A Kovacs
Role: STUDY_CHAIR
R Husson
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
Children's Hosp of Oakland
Oakland, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Palm Beach County Health Dept
Riviera Beach, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Metropolitan Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Med College of Virginia
Richmond, Virginia, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Other Identifiers
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11216
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 239
Identifier Type: -
Identifier Source: org_study_id