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Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine



Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine

For Condition: HIV Infections,Pregnancy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Female
Protocol Entry 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.
Total Enrollment: 250

Location and Contact Information:

Overall Study Official:
BardeguezAD,  Study Chair, 

Los Angeles County - USC Med Ctr
Los Angeles,  California,  90033
United States
 

Long Beach Memorial (Pediatric)
Long Beach,  California,  90801
United States
 

Children's Hosp of Boston
Boston,  Massachusetts,  021155724
United States
 

Baystate Med Ctr of Springfield
Springfield,  Massachusetts,  01199
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Howard Univ Hosp
Washington D.C.,  District of Columbia,  20060
United States
 

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Connecticut Children's Med Ctr - Pediatric
Hartford,  Connecticut,  06106
United States
 

Columbus Children's Hosp
Columbus,  Ohio,  432052696
United States
 

SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse,  New York,  13210
United States
 

Columbia Presbyterian Med Ctr
New York City,  New York,  10032
United States
 

Univ of Miami (Pediatric)
Miami,  Florida,  33161
United States
 

Bronx Lebanon Hosp Ctr
Bronx,  New York,  10457
United States
 

Univ Hosp
New Orleans,  Louisiana,  70112
United States
 

Brigham and Women's Hosp
Boston,  Massachusetts,  02115
United States
 

Tulane Univ / Charity Hosp of New Orleans
New Orleans,  Louisiana,  701122699
United States
 

San Juan City Hosp
San Juan,  ,  009367344
Puerto Rico
 

Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles,  California,  905022004
United States
 

Univ of Connecticut / Farmington
Farmington,  Connecticut,  06032
United States
 

UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla,  California,  920930672
United States
 

Johns Hopkins Hosp - Pediatric
Baltimore,  Maryland,  212874933
United States
 

Mount Sinai Med Ctr / Pediatrics
New York City,  New York,  10029
United States
 

Univ of Chicago Children's Hosp
Chicago,  Illinois,  606371470
United States
 

Children's Hosp of Washington DC
Washington D.C.,  District of Columbia,  200102916
United States
 

UCLA Med Ctr / Pediatric
Los Angeles,  California,  900951752
United States
 

Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham,  Alabama,  35294
United States
 

Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark,  New Jersey,  071032714
United States
 

Duke Univ Med Ctr
Durham,  North Carolina,  277103499
United States
 


Additional Information:
Study ID Numbers:
  ACTG 255; 
Study Start Date: 
Record last reviewed: October 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000828

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2. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients

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4. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

5. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole

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