Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02181933
First received: July 2, 2014
Last updated: July 11, 2014
Last verified: July 2014

July 2, 2014
July 11, 2014
April 1999
January 2001   (final data collection date for primary outcome measure)
Incidence of HIV transmission from a HIV positive mother to her exposed infant during the intrapartum and early postpartum period [ Time Frame: Day 28, 42 and 56-84 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02181933 on ClinicalTrials.gov Archive Site
  • Overall HIV transmission rate (including intrauterine, intrapartum and postpartum) [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • Time to infection [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • Relationship between infection and timing of maternal dose relative to birth [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • Relationship between infection and infant feeding method [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • Relationship between infection and maternal peripheral blood viral load [ Time Frame: Day 0 and 28 ] [ Designated as safety issue: No ]
  • Relationship between infection and other potential risk factors [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 84 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women
A Prospective Randomised Open Label Clinical Trial to Determine the Efficacy of Nevirapine, Compared With a Combination of ZDV + 3TC, in Decreasing the Peripartum Mother to Child Transmission of HIV. Women, Who Present After 38 Weeks Gestation or in Labour After 35 Weeks Gestation and Who Are Anti-retroviral Naive, Will be Included.

The primary objective of the study was to evaluate the efficacy of nevirapine versus ZDV+3TC (Zidovudine + Lamivudine), when administered in labor and again at postdelivery, in reducing peripartum mother to child transmission of HIV (Human Immunodeficiency Virus).

The secondary objective was to assess the overall HIV transmission rate between the 2 groups (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the relationship between infection and timing of maternal dose relative to birth, infant feeding method, maternal peripheral blood viral load, and other potential risk factors for transmission.

Following the introduction of the second and third Amendments to the Protocol, 2 substudies were added. The objectives of these substudies were to evaluate the frequency of resistance-conferring mutations to nevirapine (Amendment 2) and to ZDV+3TC (Amendment 3); to determine whether there was a reversion of any resistant virus to the wild type; and to determine if the resistant virus was transmitted from the mother to the child.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Nevirapine
  • Drug: Zidovudine (ZDV)
  • Drug: Lamivudine (3TC)
  • Experimental: Nevirapine
    Mother: two doses, Infant: one dose
    Intervention: Drug: Nevirapine
  • Active Comparator: Zidovudine (ZDV) + Lamivudine (3TC)
    Interventions:
    • Drug: Zidovudine (ZDV)
    • Drug: Lamivudine (3TC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2648
Not Provided
January 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women who present after 38 weeks gestation or in labour after 35 weeks gestation who are tested HIV positive. Estimated gestational age will be determined by one or more of the following:

    • Reliable menstrual history, which corresponds with uterine size
    • Physical examination
    • Estimated fetal weight
  • A consent form for the mother and neonate will be signed by either the mother or the guardian prior to inclusion

Exclusion Criteria:

  • Mothers who have taken any antiretrovirals in the last 12 months
  • Mothers who are not able to take oral medication
  • Mothers who present with ARDS (acute respiratory distress syndrome), septic shock or eclampsia
  • Mothers presenting in discomfort, i.e. regular painful uterine contractions, or other factors that may contribute to her not being able to understand and sign the informed consent for HIV testing and study participation
  • Use of another investigational drug or concurrent participation in another investigational protocol during the current pregnancy
  • Unwillingness or inability to reasonably comply with the protocol (i.e., mother and neonate/infant could not be followed for the full 6 weeks of the trial)
  • Grade 4 SGPT (Serum glutamate pyruvate transaminase) (>10 times the upper limit of normal value), if known prior to delivery
  • A recent history (6 months preceding the study) or current evidence of drug abuse and/or alcoholism
  • Mothers with fetuses with anomalies incompatible with life, if known prior to delivery
  • Decision to deliver the infant by elective Cesarean section
  • Amniocentesis was indicated
  • Infants with severe growth retardation diagnosed before birth

Infants who fall into the following groups will not receive treatment, but the mother-infant pair will remain in the trial

  • Infants with malformations incompatible with life
  • Life-threatening perinatal conditions which do not allow oral therapy (e.g., sepsis)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT02181933
1100.1287
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Not Provided
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP