Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Condition: Disease Transmission, Vertical; Vertical Human Immunodeficiency Virus Transmission; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: Zidovudine; Nevirapine (NVP); Epivir (3TC); Nelfinavir (NFV)
Intervention description: Given for 6 weeks. 12mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams; 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; 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; 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
Intervention MeSH terms: Lamivudine; Zidovudine; Nevirapine; Nelfinavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1735.0
Sex: All
Maximum age: 2 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; Perinatal; Prevention; Transmission; Nevirapine; Epivir; Zidovudine; Nelfinavir; ZDV; NVP; 3TC; NFV; Viracept; Viramune; HIV Seronegativity; Treatment Naive

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.
    

Eligibility criteria:

        Inclusion Criteria:

        Infants who meet all of the following criteria are eligible for the study:

          -  Mother known to be HIV-1-infected prior to labor or identified at the time of labor or
             <48 hours postpartum. HIV-1 infection for the purposes of enrollment into this study
             is defined as: (a) Single positive HIV-1 rapid test in mother or her infant; or (b)
             Historical documentation of a positive HIV-1 diagnostic test confirmed by repeat
             diagnostic testing for HIV-1 according to country guidelines in mother (written
             documentation of test results must be present in the medical record).

          -  Maternal written informed consent for study participation.

          -  Mother has not received any antiretroviral therapy during the current pregnancy prior
             to the onset of labor and delivery; women may have received intravenous or oral ZDV
             during labor. Women may have received any antiretroviral therapy in previous
             pregnancies for prevention of vertical HIV-1 transmission.

          -  Infant is <48 hours old. Infant may have received up to 48 hours of ZDV as standard
             care before study enrollment.

        Exclusion Criteria:

        Infants who meet any of the following criteria will be excluded from the study:

          -  Extreme prematurity (< 32 weeks of gestation).

          -  Birth weight <1500 grams.

          -  Presence of life-threatening conditions.

          -  Inability to take oral medication throughout the first 48 hours of life (must be able
             to receive oral medication by age 48 hours).

          -  Maternal inability to provide informed consent because of a lack of a conscious state,
             psychiatric conditions, or language barriers.

          -  Mother received any antiretroviral therapy during labor and delivery other than
             intravenous or oral ZDV.