Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nevirapine (Drug); Zidovudine (Drug)
Phase: Phase 3
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Official(s) and/or principal investigator(s):
Brooks Jackson, Study Chair
Francis Mmiro, Study Chair
Laura Guay, Study Chair
Philippa Musoke, Study Chair
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.
Official title: A Phase III Placebo-Controlled Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates
Study design: Prevention, Double-Blind, Safety Study
There is an urgent need to find a safe, effective means of preventing mother-to-infant HIV
transmission that would also be applicable and affordable in developing-country settings. The
frequency of vertical HIV-1 transmission is estimated to be 25 percent. The proposed trial
specifically will test the hypothesis that chemoprophylaxis of the fetus/neonate during labor
and delivery and the first week of life may significantly reduce the risk of perinatal HIV-1
Pregnant women infected with HIV-1 are randomized to 1 of 4 study arms and receive either NVP
or its placebo, or AZT or its placebo. Mothers in the NVP group receive a single dose of NVP
or placebo at the onset of labor and are followed to 6 to 8 weeks after delivery. Infants
born to these mothers receive at 48 to 72 hours post-delivery or discharge, whichever comes
first, a regimen of the same treatment (NVP or placebo) given to the mother. Infants are
followed for 18 months post-delivery by clinical and laboratory evaluation to determine
toxicity, evidence of HIV-1 infection, and clinical disease progression.
Mothers in the AZT group receive either a bolus of AZT or its placebo at onset of labor, then
doses every 3 hours until delivery, with follow-up to 6 to 8 weeks. Infants begin receiving
either a lower dose of AZT or placebo as soon as they can tolerate liquids by mouth, twice
daily for 7 days, and are followed for 18 months as in the NVP group.
Minimum age: N/A.
Maximum age: N/A.
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.
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.
Locations and Contacts
Missie Allen, Research Triangle Park, North Carolina 27709, United States
Click here for more information about nevirapine
Click here for more information about zidovudine
Haga clic aquí para ver información sobre este ensayo clínico en español.
Click here for more information about the HIVNET 012 study
Click here for more information on understanding HIV prevention
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)
Last updated: January 8, 2007