Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns

NCT00006396 | Completed Phase 3

• 2 other identifiers: HIVNET 01211719
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies. About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.

Conditions

HIV Infections

Keywords

Pregnancy Complications, Infectious; HIV-1; Administration, Oral; Zidovudine; Nevirapine; RNA, Viral; Disease Transmission, Vertical; Enzyme-Linked Immunosorbent Assay; Blotting, Western; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; HIV Seronegativity

Interventions

Nevirapine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers may be eligible for this study if they:
• Have been pregnant for more than 32 weeks and are at least 18 years of age.
• Are HIV-positive.
• Reside within 15 km of Mulago Hospital, the study site.
• Infants may be eligible for this study if they:
• Are born to mothers enrolled in the study.
• Have consent of the mother/guardian and, if available, the father.

You may not qualify if:

• Mothers will not be eligible for this study if they:
• Have a serious infection or illness other than HIV.
• Currently take any anti-HIV drugs.
• Participate during this pregnancy in another treatment vaccine perinatal trial.
• Received NVP or AZT within the last 6 months.
• Are allergic to any benzodiazepine.
• Abuse alcohol or other drugs.
• Have high blood pressure that is not controlled.
• Have received any anticoagulants, benzodiazepines other than the study drug, or magnesium sulfate within 2 weeks before being assigned to a study group or delivery.
• Infants will not be eligible for this study if:
• Their mother is excluded prior to being assigned to a study group.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Missie Allen

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (11)

• Eshleman SH, Mracna M, Guay L, Deseyve M, Cunningham S, Musoke P, Mmiro F, Jackson JB. Selection of nevirapine resistance (NVPR) mutations in Ugandan women and infants receiving NVP prophylaxis to prevent HIV-1 vertical transmission (HIVNET-012). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 516)

  BACKGROUND

• Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Ducar C, Deseyve M, Emel L, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Dransfield K, Bray D, Mmiro F, Jackson JB. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999 Sep 4;354(9181):795-802. doi: 10.1016/S0140-6736(99)80008-7.

  PMID: 10485720 RESULT

• Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, Nakabiito C, Sherman J, Bakaki P, Owor M, Ducar C, Deseyve M, Mwatha A, Emel L, Duefield C, Mirochnick M, Fowler MG, Mofenson L, Miotti P, Gigliotti M, Bray D, Mmiro F. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003 Sep 13;362(9387):859-68. doi: 10.1016/S0140-6736(03)14341-3.

  PMID: 13678973 RESULT

• Eshleman SH, Guay LA, Mwatha A, Brown ER, Cunningham SP, Musoke P, Mmiro F, Jackson JB. Characterization of nevirapine resistance mutations in women with subtype A vs. D HIV-1 6-8 weeks after single-dose nevirapine (HIVNET 012). J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):126-30. doi: 10.1097/00126334-200402010-00004.

  PMID: 14722443 RESULT

• Eshleman SH, Guay LA, Fleming T, Mwatha A, Mracna M, Becker-Pergola G, Musoke P, Mmiro F, Jackson JB. Survival of Ugandan infants with subtype A and D HIV-1 infection (HIVNET 012). J Acquir Immune Defic Syndr. 2002 Nov 1;31(3):327-30. doi: 10.1097/00126334-200211010-00009.

  PMID: 12439209 RESULT

• Eshleman SH, Becker-Pergola G, Deseyve M, Guay LA, Mracna M, Fleming T, Cunningham S, Musoke P, Mmiro F, Jackson JB. Impact of human immunodeficiency virus type 1 (hiv-1) subtype on women receiving single-dose nevirapine prophylaxis to prevent hiv-1 vertical transmission (hiv network for prevention trials 012 study). J Infect Dis. 2001 Oct 1;184(7):914-7. doi: 10.1086/323153. Epub 2001 Aug 13.

  PMID: 11509999 RESULT

• Eshleman SH, Mracna M, Guay LA, Deseyve M, Cunningham S, Mirochnick M, Musoke P, Fleming T, Glenn Fowler M, Mofenson LM, Mmiro F, Jackson JB. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS. 2001 Oct 19;15(15):1951-7. doi: 10.1097/00002030-200110190-00006.

  PMID: 11600822 RESULT

• Eshleman SH, Guay LA, Mwatha A, Cunningham SP, Brown ER, Musoke P, Mmiro F, Jackson JB. Comparison of nevirapine (NVP) resistance in Ugandan women 7 days vs. 6-8 weeks after single-dose nvp prophylaxis: HIVNET 012. AIDS Res Hum Retroviruses. 2004 Jun;20(6):595-9. doi: 10.1089/0889222041217518.

  PMID: 15242535 RESULT

• Eshleman SH, Guay LA, Wang J, Mwatha A, Brown ER, Musoke P, Mmiro F, Jackson JB. Distinct patterns of emergence and fading of K103N and Y181C in women with subtype A vs. D after single-dose nevirapine: HIVNET 012. J Acquir Immune Defic Syndr. 2005 Sep 1;40(1):24-9. doi: 10.1097/01.qai.0000174656.71276.d6.

  PMID: 16123677 RESULT

• Jackson JB, Parsons T, Musoke P, Nakabiito C, Donnell D, Fleming T, Mirochnick M, Mofenson L, Fowler MG, Mmiro F, Guay L. Association of cord blood nevirapine concentration with reported timing of dose and HIV-1 transmission. AIDS. 2006 Jan 9;20(2):217-22. doi: 10.1097/01.aids.0000198089.93196.84.

  PMID: 16511414 RESULT

• Eshleman SH, Hoover DR, Chen S, Hudelson SE, Guay LA, Mwatha A, Fiscus SA, Mmiro F, Musoke P, Jackson JB, Kumwenda N, Taha T. Resistance after single-dose nevirapine prophylaxis emerges in a high proportion of Malawian newborns. AIDS. 2005 Dec 2;19(18):2167-9. doi: 10.1097/01.aids.0000194800.43799.94.

  PMID: 16284468 RESULT

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Nevirapine; Zidovudine

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; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Brooks Jackson

  STUDY CHAIR

• Francis Mmiro

  STUDY CHAIR

• Laura Guay

  STUDY CHAIR

• Philippa Musoke

  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: October 10, 2000
• First Posted: August 31, 2001
• Study Completion: November 1, 2004
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)