CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,735 enrolled
Drug / intervention
Zidovudine +3 moredrug
Likely dose
Zidovudine 12 mg orally twice daily (if birthweight >2000 grams) or 8 mg orally twice daily (if birthweight <2000 grams) for 6 weeks; OR Zidovudine plus Nevirapine 12 mg per dose (if birthweight >2000 grams) or 8 mg per dose (if birthweight <2000 grams) given as three doses within first 96 hours; OR Zidovudine plus 3TC 6 mg orally twice daily (if birthweight >2000 grams) or 4 mg orally twice daily (if birthweight <2000 grams) plus Nelfinavir 200 mg orally twice daily (if birthweight >3000 grams), 150 mg orally twice daily (if birthweight 2000-3000 grams), or 100 mg orally twice daily (if birthweight <2000 grams) for 2 weeksAI-extracted
Key inclusion· 4
  • ✓Mother known to be HIV-1-infected prior to labor, at time of labor, or within 48 hours postpartum (confirmed by single rapid test or documented positive diagnostic test)
  • ✓Infant is less than 48 hours old
  • ✓Infant able to receive oral medication by 48 hours of age
  • ✓Maternal written informed consent provided for study participation
Key exclusion· 6
  • ✕Extreme prematurity (less than 32 weeks gestation)
  • ✕Birth weight less than 1500 grams
  • ✕Presence of life-threatening conditions
  • ✕Mother unable to provide informed consent due to unconsciousness, psychiatric conditions, or language barriers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00099359
NCT00099359Phase 3Completed
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Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Dec 13, 2004·Updated Dec 4, 2012

In Brief

A Phase 3 clinical trial evaluating Zidovudine, Nevirapine (NVP), and 2 other interventions for Disease Transmission, Vertical and 2 related conditions. Completed, enrolled 1,735 participants across 17 sites in 5 countries.

Detailed Summary

Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV. This study will assess the safety and efficacy of two different combinations of anti-HIV medications compared to a one drug standard regimen in preventing mother to baby transmission. The one drug standard treatment and two combinations to be studied are: 1) zidovudine, 2) zidovudine/nevirapine and 3) zidovudine/lamivudine/nelfinavir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDisease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
CountriesArgentina, Brazil, Puerto Rico, South Africa, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2004
Enrollment StartFeb 1, 2004
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 21.6 years ago

Interventions

Zidovudinedrug

Given for 6 weeks. 12mg PO BID if birthweight (BW) \> 2000 grams 8 mg PO BID if BW \< 2000 grams

Nevirapine (NVP)drug

Standard of Care (Zidovudine) plus 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

Epivir (3TC)drug

Stand of care (Zidovudine) plus 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

Nelfinavir (NFV)drug

200 mg BID if birth weight (BW) \> 3000 grams for 2 weeks;150 mg BID if BW \> 2000-3000 grams for 2 weeks; 100 mg BID BW \</= 2000 grams for 2 weeks