Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission

NCT00021671 | Completed Phase 3

• 2 other identifiers: HIVNET 02411622
• Study Type: interventional
• Target: 3,720
• Locations: 1 country
• Sites: 1

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

Conditions

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

Interventions

Erythromycin DRUG

Nevirapine DRUG

Ampicillin sodium DRUG

Metronidazole DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Megan Valentine

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (10)

• 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.

  PMID: 9099500 BACKGROUND

• 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.

  PMID: 8098783 BACKGROUND

• 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.

  PMID: 7491136 BACKGROUND

• 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.

  PMID: 9307346 BACKGROUND

• 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.

  PMID: 16227794 RESULT

• 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.

  PMID: 16875654 RESULT

• 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.

  PMID: 16522393 RESULT

• 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.

  PMID: 19664210 DERIVED

• 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.

  PMID: 17978109 DERIVED

• 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.

  PMID: 17267841 DERIVED

MeSH Terms

Conditions

HIV Infections; Chorioamnionitis

Interventions

Erythromycin; Nevirapine; Ampicillin; Metronidazole

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Taha E Taha, MD, PhD

  Johns Hopkins University

  STUDY CHAIR

• Robert Goldenberg, MD

  Department of Obstetrics and Gynecology, University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2001
• First Posted: August 31, 2001
• Study Completion: November 1, 2004
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)