A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

NCT00000839 | Completed Phase 1

• 2 other identifiers: ACTG 24911226
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 13

Brief Summary

To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are either intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following maternal treatment with ddI during the third trimester of pregnancy. AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for HIV infection. Although ddI has been approved for use in HIV-infected adults and older children, the safety and pharmacokinetics of ddI in pregnant women has not yet been determined.

Conditions

HIV Infections; Pregnancy

Keywords

Pregnancy Trimester, Third; Pregnancy; Pregnancy Complications, Infectious; Didanosine; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Didanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Bristol-Myers Squibb: collaborator

Study Sites (13)

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, 90095, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 92093, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

New Orleans, Louisiana, 70112, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

NJ Med. School CRS

Newark, New Jersey, 07103, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 27710, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

San Juan, 00936, Puerto Rico

Location

Related Publications (3)

• Livingston E, Patil S, Unadkat J, McKinney R, Abreu E, Bardequez A, O'Sullivan M. Placental transfer of didanosine (ddI) and initial evaluation of didanosine toxicity in HIV-1 infected pregnant women and their offspring. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:121 (abstract no 226)

  BACKGROUND

• 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

• Patil SD, Livingston E, McKinney RE, Abreu E, O'Sullivan MJ, Bardequez A, Unadkat JD. Does pregnancy affect the pharmacokinetics of didanosine (ddI) in HIV-1 infected women? Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:121 (abstract no 225)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Livingston E

  STUDY CHAIR

• Bartlett JA

  STUDY CHAIR

• Unadkat J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (11); PR (2)