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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Nevirapine

Zidovudine (ZDV)

Lamivudine (3TC)

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nevirapine

Zidovudine (ZDV) + Lamivudine (3TC)

Arm Description

Mother: two doses, Infant: one dose

Outcomes

Primary Outcome Measures

Incidence of HIV transmission from a HIV positive mother to her exposed infant during the intrapartum and early postpartum period

Secondary Outcome Measures

Overall HIV transmission rate (including intrauterine, intrapartum and postpartum)

Time to infection

Relationship between infection and timing of maternal dose relative to birth

Relationship between infection and infant feeding method

Relationship between infection and maternal peripheral blood viral load

Relationship between infection and other potential risk factors

Number of patients with adverse events

Full Information

NCT ID

NCT02181933

First Posted

July 2, 2014

Last Updated

July 11, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02181933

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

April 1999 (undefined)

Primary Completion Date

January 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2648 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nevirapine

Arm Type

Experimental

Arm Description

Mother: two doses, Infant: one dose

Arm Title

Zidovudine (ZDV) + Lamivudine (3TC)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Nevirapine

Intervention Type

Drug

Intervention Name(s)

Zidovudine (ZDV)

Intervention Type

Drug

Intervention Name(s)

Lamivudine (3TC)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Overall HIV transmission rate (including intrauterine, intrapartum and postpartum)

Time Frame

up to 84 days

Title

Time to infection

Time Frame

up to 84 days

Title

Relationship between infection and timing of maternal dose relative to birth

Time Frame

up to 84 days

Title

Relationship between infection and infant feeding method

Time Frame

up to 84 days

Title

Relationship between infection and maternal peripheral blood viral load

Time Frame

Day 0 and 28

Title

Relationship between infection and other potential risk factors

Time Frame

up to 84 days

Title

Number of patients with adverse events

Time Frame

up to 84 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1287_U01-3282.pdf

Description

Related Info

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

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