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Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
This study has been completed.
First Received: July 31, 2001   Last Updated: July 31, 2008   History of Changes
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00021671
  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 III

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS and Pregnancy Antibiotics
Drug Information available for: Ampicillin sodium Ampicillin Erythromycin Gluceptate Metronidazole hydrochloride Metronidazole phosphate Erythromycin Nevirapine Metronidazole Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate Ampicillin trihydrate
U.S. FDA Resources

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

Estimated Enrollment: 3720
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
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institute on Drug Abuse (NIDA)
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:
Click here for more information about nevirapine  This link exits the ClinicalTrials.gov site
Click here for more information about HIV and pregnancy  This link exits the ClinicalTrials.gov site
Click here for more information on medication regimens for HIV positive pregnant women  This link exits the ClinicalTrials.gov site
Click here for more information on after birth care for HIV positive women and their babies  This link exits the ClinicalTrials.gov site
Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site

Publications:
Chi BH, Wang L, Read JS, Sheriff M, Fiscus S, Brown ER, Taha TE, Valentine M, Goldenberg R. Timing of maternal and neonatal dosing of nevirapine and the risk of mother-to-child transmission of HIV-1: HIVNET 024. AIDS. 2005 Nov 4;19(16):1857-64.
Goldenberg RL, Mudenda V, Read JS, Brown ER, Sinkala M, Kamiza S, Martinson F, Kaaya E, Hoffman I, Fawzi W, Valentine M, Taha TE; for the HPTN 024 Study Team. HPTN 024 study: Histologic chorioamnionitis, antibiotics and adverse infant outcomes in a predominantly HIV-1-infected African population. Am J Obstet Gynecol. 2006 Jul 25; [Epub ahead of print]
Goldenberg RL, Mwatha A, Read JS, Adeniyi-Jones S, Sinkala M, Msmanga G, Martinson F, Hoffman I, Fawzi W, Valentine M, Emel L, Brown E, Mudenda V, Taha TE; Hptn024 Team. The HPTN 024 Study: the efficacy of antibiotics to prevent chorioamnionitis and preterm birth. Am J Obstet Gynecol. 2006 Mar;194(3):650-61.
Goldenberg RL, Andrews WW, Yuan AC, MacKay HT, St Louis ME. Sexually transmitted diseases and adverse outcomes of pregnancy. Clin Perinatol. 1997 Mar;24(1):23-41. Review.
St Louis ME, Kamenga M, Brown C, Nelson AM, Manzila T, Batter V, Behets F, Kabagabo U, Ryder RW, Oxtoby M, et al. Risk for perinatal HIV-1 transmission according to maternal immunologic, virologic, and placental factors. JAMA. 1993 Jun 9;269(22):2853-9.
Hauth JC, Goldenberg RL, Andrews WW, DuBard MB, Copper RL. Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis. N Engl J Med. 1995 Dec 28;333(26):1732-6.
Mercer BM, Miodovnik M, Thurnau GR, Goldenberg RL, Das AF, Ramsey RD, Rabello YA, Meis PJ, Moawad AH, Iams JD, Van Dorsten JP, Paul RH, Bottoms SF, Merenstein G, Thom EA, Roberts JM, McNellis D. Antibiotic therapy for reduction of infant morbidity after preterm premature rupture of the membranes. A randomized controlled trial. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. JAMA. 1997 Sep 24;278(12):989-95.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Mwinga K, Vermund SH, Chen YQ, Mwatha A, Read JS, Urassa W, Carpenetti N, Valentine M, Goldenberg RL. Selected hematologic and biochemical measurements in African HIV-infected and uninfected pregnant women and their infants: the HIV Prevention Trials Network 024 protocol. BMC Pediatr. 2009 Aug 7;9:49.
Chi BH, Wang L, Read JS, Taha TE, Sinkala M, Brown ER, Valentine M, Martinson F, Goldenberg RL. Predictors of stillbirth in sub-saharan Africa. Obstet Gynecol. 2007 Nov;110(5):989-97.
Goldenberg RL, Andrews WW, Hoffman I, Fawzi W, Valentine M, Young A, Read JS, Brown ER, Mudenda V, Kafulafula G, Mwinga K, Taha TE. Fetal fibronectin and adverse infant outcomes in a predominantly human immunodeficiency virus-infected African population: a randomized controlled trial. Obstet Gynecol. 2007 Feb;109(2 Pt 1):392-401.

Study ID Numbers: HIVNET 024
Study First Received: July 31, 2001
Last Updated: July 31, 2008
ClinicalTrials.gov Identifier: NCT00021671     History of Changes
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:
Placenta Diseases
Erythromycin stearate
Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Physiological Effects of Drugs
Infection
Fetal Membranes, Premature Rupture
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
 Antiparasitic Agents
Fetal Diseases
Anti-Retroviral Agents
Therapeutic Uses
Chorioamnionitis
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Gastrointestinal Agents
Obstetric Labor Complications
Ampicillin
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009



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