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

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ClinicalTrials.gov Identifier: NCT00099359
Recruitment Status : Completed
First Posted : December 13, 2004
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Collaborator:
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)

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

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
  Description
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
ARM B (ZDV + NVP)

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

ARM C (ZDV + 3TC + NFV)

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

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

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
No text entered.


  More Information