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NCT01618305 · ClinicalTrials.gov registry record · Phase 4
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
A Phase 4 study, sponsored by Westat.
- Completed
- Registry status
- Phase 4
- Development phase
- 408
- Enrollment target
NCT01618305: Completed Phase 4 study, sponsored by Westat.
NCT01618305 is a Phase 4 study that has completed, run by Westat. The registered enrollment target is 408 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618305, a Phase 4 study, has completed, sponsored by Westat.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 408 participants
- Enrollment target
Study Summary
HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study examined the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who were between 20 and 36 weeks pregnant when they entered the study.
Primary Outcome
If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered.
Interventions
- DRUG Efavirenz
- DRUG Raltegravir
- DRUG Lamivudine/zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2013-09-05 |
| Est. Completion | 2018-12-11 |
| Phase | Phase 4 |
What the finished NCT01618305 record still lists
NCT01618305 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 3 interventions - of which Efavirenz is the first listed.
NCT01618305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01618305 about?
NCT01618305 is a clinical study titled "Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission". HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study examined the virologic response, safety, and tolerability of two different ARV medic...
What is the current status of trial NCT01618305?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 408 participants. The study started on 2013-09-05. Estimated completion is 2018-12-11.
What interventions are being tested in trial NCT01618305?
The interventions under investigation include: Efavirenz (DRUG), Raltegravir (DRUG), Lamivudine/zidovudine (DRUG).
Who is sponsoring clinical trial NCT01618305?
This trial is sponsored by Westat, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01618305's enrollment target sits among peer trials
408 208th of 2000 higher than 1,793 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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