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Trial record 77 of 3132 for:    HIV Infections | NIH

Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

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ClinicalTrials.gov Identifier: NCT00021671
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 14, 2012
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE July 31, 2001
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date February 14, 2012
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00021671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Official Title  ICMJE Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Brief Summary

The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby.

A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby.

[Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]

Detailed Description

Obstetric risk factors for HIV maternal-child transmission (MCT) include preterm birth, prolonged rupture of the membranes, and chorioamnionitis. Many preterm births are associated with and likely caused by chorioamnionitis. The relationship between bacterial vaginosis, preterm birth, histologic chorioamnionitis, and perinatal transmission of HIV has been consistently demonstrated. Perinatal HIV transmission is more common in preterm infants, and there is now evidence that subclinical chorioamnionitis is a substantial risk factor for MCT. For this study, the primary hypothesis is that early and appropriate treatment of subclinical chorioamnionitis prior to the onset of spontaneous preterm labor, and/or antibiotic treatment during labor, to prevent premature rupture of membrane-associated-chorioamnionitis, will reduce the risk of perinatal HIV transmission.

[Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]

At 20 to 24 weeks, women who are randomized to receive antibiotics receive metronidazole and erythromycin for 7 days. Women randomized to the control group receive identically appearing placebos. With the onset of contractions and/or premature rupture of membranes, study participants will initiate a second oral course of antibiotics consisting of metronidazole and ampicillin or placebo every 4 hours, continuing after delivery until the course is completed. All HIV-infected women and their neonates will be offered the HIVNET 012 nevirapine (NVP) regimen. If the mother accepts the NVP for herself and her baby, she will be given 1 dose of NVP to be taken at onset of labor, and her baby will receive 1 dose of NVP at 72 hours post-birth or discharge, whichever occurs earlier. If the mother refuses NVP or is uninfected, she will receive a matched placebo at the 26- to 30-week visit to preserve participant confidentiality. This study takes place in Blantyre and Lilongwe, Malawi, in Lusaka, Zambia, and in Dar es Salaam, Tanzania.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: Double
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Erythromycin
  • Drug: Nevirapine
  • Drug: Ampicillin sodium
  • Drug: Metronidazole
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
3720
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

  • HIV positive.
  • 20 to 24 weeks pregnant.
  • Willing to take the planned antibiotic treatment.
  • Planning to deliver at 1 of the study sites.
  • Willing to come back for follow-up visits for 1 year after the baby is born.

Exclusion Criteria

  • Have taken antibiotics, except for syphilis or gonorrhea, within the last 2 weeks.
  • Are allergic to penicillin, ampicillin, erythromycin, or metronidazole.
  • Have major illnesses, such as diabetes, severe kidney or heart disease, or active tuberculosis, which might affect the pregnancy.
  • Are having major problems with the pregnancy, such as placenta previa, ruptured membranes, or multiple pregnancy.
  • Have a central nervous system disease, such as seizures.
  • Are taking anticoagulant drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00021671
Other Study ID Numbers  ICMJE HIVNET 024
11622 ( Registry Identifier: DAIDS ES )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Study Chair: Taha E Taha, MD, PhD Johns Hopkins University
Study Chair: Robert Goldenberg, MD Department of Obstetrics and Gynecology, University of Alabama at Birmingham
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP