A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth

NCT00001007 | Completed Phase 1

• 2 other identifiers: ACTG 049FDA 9D
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief Summary

To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth.

Conditions

HIV Infections

Keywords

Pregnancy; Pregnancy Complications, Infectious; Infant, Newborn, Diseases; Infusions, Intravenous; Drug Evaluation; Administration, Oral; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infant gestation period must have been = or \> 36 weeks and birthweight must = or \> 2000 grams. Active infection must not be present at the time of entry into the study although an HIV culture or P24 serum antigen determination must be obtained prior to study entry. The child must have a life expectancy greater than 3 months. Parents or guardian must be available to give informed consent.
• Prior Medication:
• Allowed on a case-by-case basis:
• Some essential supportive therapies including antibiotics.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Any of the following laboratory findings within 2 weeks of study entry.
• A total bilirubin \> 2 times age-adjusted upper limit of normal.
• Liver transaminase values \> 3 x upper limit of normal.
• Serum creatinine \> 1.5 x upper limit of normal.
• Total granulocyte count \< 1500 cells/mm3.
• Hemoglobin \< 10 g/dl or hemoglobinopathy.
• A urine toxicology screen positive for any drug or chemical.
• Infants must not have hemoglobinopathy or active infection at entry.
• Prior Medication:
• Excluded within 2 months of study entry:
• Antiretroviral agents.
• Excluded within 4 weeks of study entry:
• Immunomodulating agents including steroids, interferon, isoprinosine, and interleukin.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Study Sites (6)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford Univ School of Medicine

Stanford, California, 94305, United States

Location

Johns Hopkins Hosp - Pediatric

Baltimore, Maryland, 212874933, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Related Publications (6)

• Vance E, Guzman J, Bitar M, Kazanjian P. Clarithromycin and zidovudine pharmacokinetic study. Int Conf AIDS. 1994 Aug 7-12;10(2):201 (abstract no PB0816)

  BACKGROUND

• Vance E, Watson-Bitar M, Gustavson L, Kazanjian P. Pharmacokinetics of clarithromycin and zidovudine in patients with AIDS. Antimicrob Agents Chemother. 1995 Jun;39(6):1355-60. doi: 10.1128/AAC.39.6.1355.

  PMID: 7574530 BACKGROUND

• Boucher FD, Modlin JF, Weller S, Ruff A, Mirochnick M, Pelton S, Wilfert C, McKinney R Jr, Crain MJ, Elkins MM, et al. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. J Pediatr. 1993 Jan;122(1):137-44. doi: 10.1016/s0022-3476(05)83507-3.

  PMID: 8419601 BACKGROUND

• Collart L, Blaschke TF, Boucher F, Prober CG. Potential of population pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates. Dev Pharmacol Ther. 1992;18(1-2):71-80.

  PMID: 1483365 BACKGROUND

• Polis MA, Piscitelli SC, Vogel S, Witebsky FG, Conville PS, Petty B, Kovacs JA, Davey RT Jr, Walker RE, Falloon J, Metcalf JA, Craft C, Lane HC, Masur H. Clarithromycin lowers plasma zidovudine levels in persons with human immunodeficiency virus infection. Antimicrob Agents Chemother. 1997 Aug;41(8):1709-14. doi: 10.1128/AAC.41.8.1709.

  PMID: 9257746 BACKGROUND

• Balis FM, Pizzo PA, Eddy J, Wilfert C, McKinney R, Scott G, Murphy RF, Jarosinski PF, Falloon J, Poplack DG. Pharmacokinetics of zidovudine administered intravenously and orally in children with human immunodeficiency virus infection. J Pediatr. 1989 May;114(5):880-4. doi: 10.1016/s0022-3476(89)80158-1.

  PMID: 2715903 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious; Infant, Newborn, Diseases; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Modlin J

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: July 15, 2008

Record last verified: 2003-01

Locations

US (6)