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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006396
First received: October 10, 2000
Last updated: February 13, 2012
Last verified: February 2012

October 10, 2000
February 13, 2012
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Complete list of historical versions of study NCT00006396 on ClinicalTrials.gov Archive Site
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Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns
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

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.

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 transmission.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
  • Drug: Nevirapine
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
November 2004
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Inclusion Criteria

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.

Exclusion Criteria

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.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006396
HIVNET 012, 11719
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Brooks Jackson
Study Chair: Francis Mmiro
Study Chair: Laura Guay
Study Chair: Philippa Musoke
National Institute of Allergy and Infectious Diseases (NIAID)
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP