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Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Erythromycin
Nevirapine
Ampicillin sodium
Metronidazole
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Drug Therapy, Combination, Ampicillin, Nevirapine, Disease Transmission, Vertical, Anti-Infective Agents, Erythromycin, Reverse Transcriptase Inhibitors, Metronidazole, Anti-HIV Agents, Chorioamnionitis, HIV Seronegativity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Megan Valentine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 31, 2001
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00021671
Brief Title
Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Official Title
Phase III Trial of Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Ampicillin, Nevirapine, Disease Transmission, Vertical, Anti-Infective Agents, Erythromycin, Reverse Transcriptase Inhibitors, Metronidazole, Anti-HIV Agents, Chorioamnionitis, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Enrollment
3720 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erythromycin
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Ampicillin sodium
Intervention Type
Drug
Intervention Name(s)
Metronidazole

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taha E Taha, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Goldenberg, MD
Organizational Affiliation
Department of Obstetrics and Gynecology, University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
Megan Valentine
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9099500
Citation
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.
Results Reference
background
PubMed Identifier
8098783
Citation
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.
Results Reference
background
PubMed Identifier
7491136
Citation
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. doi: 10.1056/NEJM199512283332603.
Results Reference
background
PubMed Identifier
9307346
Citation
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.
Results Reference
background
PubMed Identifier
16227794
Citation
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. doi: 10.1097/01.aids.0000189863.82429.2f.
Results Reference
result
PubMed Identifier
16875654
Citation
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. doi: 10.1016/j.ajog.2006.05.046. Epub 2006 Jul 26.
Results Reference
result
PubMed Identifier
16522393
Citation
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. doi: 10.1016/j.ajog.2006.01.004.
Results Reference
result
PubMed Identifier
19664210
Citation
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.
Results Reference
derived
PubMed Identifier
17978109
Citation
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. doi: 10.1097/01.AOG.0000281667.35113.a5.
Results Reference
derived
PubMed Identifier
17267841
Citation
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. doi: 10.1097/01.AOG.0000247628.68415.00. Erratum In: Obstet Gynecol. 2007 Oct;110(4):936.
Results Reference
derived

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Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

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