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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006396
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 14, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine Drug: Zidovudine Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Masking: Double
Primary Purpose: Prevention
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
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006396

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United States, North Carolina
Missie Allen
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
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
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00006396    
Other Study ID Numbers: HIVNET 012
11719 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy Complications, Infectious
Administration, Oral
RNA, Viral
Disease Transmission, Vertical
Enzyme-Linked Immunosorbent Assay
Blotting, Western
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
HIV Seronegativity
Additional relevant MeSH terms:
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Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers