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COMPLETED Phase 4

IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women

NCT00955968 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,653 participants
Start Date 2010-01-01
Est. Completion 2016-08-31
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00955968

The ClinicalTrials.gov registry entry for NCT00955968 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,653 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00955968 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00955968?

The interventions under investigation include: Highly active antiretroviral therapy (HAART) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00955968?

This trial is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial