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Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 13, 2004
Last Update Posted: December 4, 2012
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.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Results First Submitted: April 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Disease Transmission, Vertical
Vertical Human Immunodeficiency Virus Transmission
HIV Infections
Interventions: Drug: Zidovudine
Drug: Nevirapine (NVP)
Drug: Epivir (3TC)
Drug: Nelfinavir (NFV)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was enrolled on 02/27/2004 and the study ended 02/28/2011. A total of 17 sites in Brazil, South Africa, Argentina and the U.S. participated in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Arm A (ZDV Only) Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams

Standard of care (Zidovudine) plus Nevirapine (NVP)

NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :

12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams


Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND

NFV, given for 2 weeks:

200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams

Participant Flow:   Overall Study
    Arm A (ZDV Only)   ARM B (ZDV + NVP)   ARM C (ZDV + 3TC + NFV)
STARTED   581   580   574 
COMPLETED   527   515   506 
NOT COMPLETED   54   65   68 
Death                11                15                17 
Withdrawal by Subject                19                19                23 
Lost to Follow-up                15                24                24 
moved out of area                9                7                4 

  Baseline Characteristics

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Infant HIV Infection Status   [ Time Frame: 3 months ]

2.  Primary:   Participants With Serious Adverse Events   [ Time Frame: through age 6 months. ]

3.  Secondary:   Infant HIV-1 Infection Status   [ Time Frame: birth ]

4.  Secondary:   Participant Deaths   [ Time Frame: through age 6 months ]

5.  Secondary:   3TC and NFV Pharmacokinetics   [ Time Frame: through age 14 days ]

6.  Secondary:   Risk Factors for Perinatal HIV-1 Transmission   [ Time Frame: through age 3 months ]

7.  Secondary:   NVP Pharmacokinetics   [ Time Frame: 14 days ]

8.  Secondary:   Clinical Covariates of HIV-1 Infection   [ Time Frame: through age 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information