A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
A Phase I Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection
2 other identifiers
interventional
180
2 countries
47
Brief Summary
To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
- +5 more criteria
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
Children's Hosp of Oakland
Oakland, California, 946091809, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Children's Hosp of Denver
Denver, Colorado, 802181088, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33311, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Palm Beach County Health Dept
Riviera Beach, Florida, 33404, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Children's Hosp of Michigan
Detroit, Michigan, 48201, 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 New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208, United States
Schneider Children's Hosp
New Hyde Park, New York, 11040, United States
Metropolitan Hosp Ctr
New York, New York, 10029, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507, United States
Med College of Virginia
Richmond, Virginia, 23219, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
A Kovacs
- STUDY CHAIR
R Husson