Clinical trial NCT00000828: Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Official title: Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Pregnancy
Keywords: Pregnancy
Pregnancy Complications, Infectious
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Drug Resistance, Microbial
Disease Transmission, Vertical
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 250
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission.

Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.

Detailed description: Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.

HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.

Eligibility criteria: Inclusion Criteria

Prior Medication: Required:

* At least 6 months of prior AZT, including continuously during the current pregnancy.

Patients must have:

* HIV seropositivity.
* CD4 count \<= 300 cells/mm3.
* Gestational age of 20-36 weeks, with intention to carry pregnancy to term.
* At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome.

Concurrent Medication:

Excluded:

* Antiretrovirals other than AZT.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham Schl of Med / Pediatrics
state: Alabama
city: La Jolla
country: United States
facility: UCSD Med Ctr / Pediatrics / Clinical Sciences
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial (Pediatric)
state: California
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Los Angeles
country: United States
facility: UCLA Med Ctr / Pediatric
state: California
city: Los Angeles
country: United States
facility: Harbor - UCLA Med Ctr / UCLA School of Medicine
state: California
city: Farmington
country: United States
facility: Univ of Connecticut / Farmington
state: Connecticut
city: Hartford
country: United States
facility: Connecticut Children's Med Ctr - Pediatric
state: Connecticut
city: Washington
country: United States
facility: Children's Hosp of Washington DC
state: District of Columbia
city: Washington
country: United States
facility: Howard Univ Hosp
state: District of Columbia
city: Miami
country: United States
facility: Univ of Miami (Pediatric)
state: Florida
city: Chicago
country: United States
facility: Univ of Chicago Children's Hosp
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ / Charity Hosp of New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Univ Hosp
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp - Pediatric
state: Maryland
city: Boston
country: United States
facility: Children's Hosp of Boston
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hosp
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Med Ctr of Springfield
state: Massachusetts
city: Newark
country: United States
facility: Univ of Medicine & Dentistry of New Jersey / Univ Hosp
state: New Jersey
city: Bronx
country: United States
facility: Bronx Lebanon Hosp Ctr
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr / Pediatrics
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: New York
country: United States
facility: Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Health Sciences Ctr at Syracuse / Pediatrics
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Columbus
country: United States
facility: Columbus Children's Hosp
state: Ohio
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp
Study officials:
name: Bardeguez AD
role: STUDY_CHAIR
name: Pitt J
role: STUDY_CHAIR
References:
citation: Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. doi: 10.1097/00003081-199606000-00009. No abstract available.
citation: Bardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)
citation: Japour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)
citation: Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402. doi: 10.1056/NEJM199908053410602.