Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00021671
First received: July 31, 2001
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.]


Condition Intervention Phase
HIV Infections
Drug: Erythromycin
Drug: Nevirapine
Drug: Ampicillin sodium
Drug: Metronidazole
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 3720
Study Completion Date: November 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021671

Locations
United States, North Carolina
Megan Valentine
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00021671     History of Changes
Other Study ID Numbers: HIVNET 024, 11622
Study First Received: July 31, 2001
Last Updated: February 13, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
Ampicillin
Nevirapine
Disease Transmission, Vertical
Anti-Infective Agents
Erythromycin
Reverse Transcriptase Inhibitors
Metronidazole
Anti-HIV Agents
Chorioamnionitis
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Chorioamnionitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Ampicillin
Anti-Bacterial Agents
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Infective Agents
Metronidazole
Nevirapine
Antibiotics, Antitubercular
Reverse Transcriptase Inhibitors
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014