Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission - Full Text View

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:

MedlinePlus related topics: Antibiotics HIV/AIDS

Drug Information available for: Ampicillin sodium Ampicillin Erythromycin Metronidazole Erythromycin stearate Erythromycin ethylsuccinate Erythromycin phosphate Ampicillin trihydrate Metronidazole hydrochloride Nevirapine

Genetic and Rare Diseases Information Center resources: Placenta Disorder

U.S. FDA Resources

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


Ages Eligible for Study:	Child, Adult, Senior
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

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 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

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; 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 Oct;195(4):1065-74. Epub 2006 Jul 26.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1186/1471-2431-9-49.

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. Erratum in: Obstet Gynecol. 2007 Oct;110(4):936.


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:


Anti-Bacterial Agents HIV Infections Chorioamnionitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Fetal Diseases Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications	Placenta Diseases Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate Ampicillin Metronidazole Nevirapine Reverse Transcriptase Inhibitors Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016