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NCT00955968 · ClinicalTrials.gov registry record · Phase 4
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
A Phase 4 study of HIV Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,653
- Enrollment target
- 20
- Study locations
NCT00955968: Completed Phase 4 study of HIV Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
NCT00955968 is a Phase 4 study of HIV Infection that has completed, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. The registered enrollment target is 1,653 participants, above the 220-participant average among 73 other HIV Infection trials with a reported enrollment target (651% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955968, a Phase 4 study of HIV Infection, has completed, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,653 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study was designed to determine whether continuation of HAART after delivery or other pregnancy outcome reduced morbidity and mortality compared to discontinuation and re-initiation of HAART when protocol specified criteria were met.
Primary Outcome
AIDS defining illness, serious non-AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.
Conditions Studied
Interventions
- DRUG Highly active antiretroviral therapy (HAART)
Study Locations (20)
California
- University of Southern California MCA Center (5048) - Alhambra
- David Geffen School of Medicine at UCLA (5112) - Los Angeles
- UCSD Mother-Child-Adolescent HIV Program (4601) - San Diego
- Harbor (UCLA) Medical Center (5045) - Torrance
Florida
- Children's Diagnostic and Treatment Center (5055) - Fort Lauderdale
- University of Florida at Jacksonville (5051) - Jacksonville
- University of Miami Pediatric/Perinatal Clinical Research Site (4201) - Miami
- University of South Florida at Tampa (5018) - Tampa
District of Columbia
- Howard University (5044) - Washington D.C.
- Georgetown University (1008) - Washington D.C.
- Washington Hospital Center (5023) - Washington D.C.
New York
- Metropolitan Hospital (5003) - New York
- SUNY Stony Brook University Medical Center (5040) - Stony Brook
- Bronx-Lebanon Hospital Center (5114) - The Bronx
Colorado
- University of Colorado (5052) - Aurora
Illinois
- Ann & Robert H Lurie Children's Hospital of Chicago (4001) - Chicago
Louisiana
- Tulane University (5095) - New Orleans
Maryland
- Johns Hopkins University School of Medicine (5092) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,653 participants |
| Start Date | 2010-01-01 |
| Est. Completion | 2016-08-31 |
| Phase | Phase 4 |
What the finished NCT00955968 record still lists
NCT00955968 is an interventional study that assigns participants to a tested intervention. Its 1,653 participants enrollment target places it among the larger protocols in the corpus, above the 220-participant average among 73 other HIV Infection trials with a reported enrollment target (651% higher).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which Highly active antiretroviral therapy (HAART) is the first listed.
NCT00955968 names 20 study sites across 10 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00955968 about?
NCT00955968 is a clinical study titled "IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women". This study was a randomized strategy trial conducted among women who received highly active antiretroviral therapy (HAART) during pregnancy for purposes of prevention of mother-to-child transmission (PMTCT) of HIV but did not otherwise meet criteria to initiate HAART for their own health. The study ...
What is the current status of trial NCT00955968?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,653 participants. The study started on 2010-01-01. Estimated completion is 2016-08-31.
What conditions does trial NCT00955968 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00955968?
The interventions under investigation include: Highly active antiretroviral therapy (HAART) (DRUG).
Who is sponsoring clinical trial NCT00955968?
This trial is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00955968 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00955968's enrollment target sits among peer trials
1,653 3rd of 73 higher than 71 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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.
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