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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00000839 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
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Scientific title:
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A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women |
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Date of first enrolment:
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November 1994 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000839 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Bartlett JA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Livingston E |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Unadkat J |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria
Concurrent Medication:
Allowed:
- Aerosolized pentamidine.
- IV AZT during labor.
Patients must have:
- HIV infection.
- CD4 count > 50 and < 350 cells/mm3.
- AZT intolerance or resistance.
- Gestational age at least 26 weeks but not more than 36 weeks.
- Consent of guardian if necessary. The father of the fetus must also provide consent
if available after reasonable attempts have been made to contact him.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Multiple gestation.
- Current obstetrical complication, such as major anomalies, growth retardation,
abnormal fluid level, fetal hydrops, or placental abruption (placenta previa is
allowed).
- No access to a participating ACTU.
Concurrent Medication:
Excluded:
- Drugs that might aggravate pancreatitis, such as steroids, isoniazid, and parenteral
pentamidine.
- Antiretrovirals other than ddI (although IV AZT is allowed during labor).
Patients with the following prior conditions are excluded:
- History of stillbirth, neonatal loss, or previous infant with anomaly (history of
preeclampsia or preterm labor is permitted).
- History of maternal medical complications including but not limited to malabsorption
syndrome, pancreatitis, neurological complications including grade 2 or worse
peripheral neuropathy, symptomatic cholelithiasis, or prior active CMV disease
requiring ganciclovir or foscarnet.
- History of poor medical compliance not related to access to medical care.
Prior Medication:
Excluded:
- ddI within 24 hours prior to study entry.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Pregnancy
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Intervention(s)
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Drug: Didanosine
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Secondary ID(s)
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11226
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ACTG 249
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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