HIV InfectionsPhase 3NCT02181933
Efficacy of Nevirapine Compared to ZDV + 3TC Administered in Labor and Again at Postdelivery in HIV Positive Women
A Phase 3 study testing Nevirapine, Zidovudine (ZDV) and Lamivudine (3TC) in people with HIV Infections, run by Boehringer Ingelheim.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, Zidovudine (ZDV) and Lamivudine (3TC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,648 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Jan 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
About this study
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.
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.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Zidovudine (ZDV), Lamivudine (3TC)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
Zidovudine (ZDV)Drug
Lamivudine (3TC)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nevirapine | Experimental | Mother: two doses, Infant: one dose Receives: Drug: Nevirapine |
| Zidovudine (ZDV) + Lamivudine (3TC) | Active comparator | Not described Receives: Drug: Zidovudine (ZDV); Drug: Lamivudine (3TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HIV transmission from a HIV positive mother to her exposed infant during the intrapartum and early postpartum period
Measured: Day 28, 42 and 56-84
Secondary outcomes (7)
Overall HIV transmission rate (including intrauterine, intrapartum and postpartum)
Measured: up to 84 days
Time to infection
Measured: up to 84 days
Relationship between infection and timing of maternal dose relative to birth
Measured: up to 84 days
Relationship between infection and infant feeding method
Measured: up to 84 days
Relationship between infection and maternal peripheral blood viral load
Measured: Day 0 and 28
Relationship between infection and other potential risk factors
Measured: up to 84 days
Number of patients with adverse events
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 1999
- Primary completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181933
- Sponsor's protocol ID
- 1100.1287
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02181933
- Acronym / sponsor ID
- 1100.1287
- Conditions
- HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,648 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Jan 2001 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevirapine | Experimental | Drug: NevirapineMother: two doses, Infant: one dose |
| Zidovudine (ZDV) + Lamivudine (3TC) | Active comparator | Drug: Zidovudine (ZDV), Drug: Lamivudine (3TC) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- A consent form for the mother and neonate will be signed by either the mother or the guardian prior to inclusion
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nevirapine | Drug | Nevirapine |
| Zidovudine (ZDV) | Drug | Zidovudine (ZDV) + Lamivudine (3TC) |
| Lamivudine (3TC) | Drug | Zidovudine (ZDV) + Lamivudine (3TC) |
Primary outcome
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
7 secondary outcomes
Overall HIV transmission rate (including intrauterine, intrapartum and postpartum)
Time frame: up to 84 days
Time to infection
Time frame: up to 84 days
Relationship between infection and timing of maternal dose relative to birth
Time frame: up to 84 days
Relationship between infection and infant feeding method
Time frame: up to 84 days
Relationship between infection and maternal peripheral blood viral load
Time frame: Day 0 and 28
Relationship between infection and other potential risk factors
Time frame: up to 84 days
Number of patients with adverse events
Time frame: up to 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine, Zidovudine (ZDV) and Lamivudine (3TC) in people with HIV Infections, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.