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COMPLETED Phase 2

Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis

NCT02165202 · View on ClinicalTrials.gov ↗

Study Summary

This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.

Interventions

  • DRUG Placebo
  • DRUG Rilpivirine

Study Locations (4)

New Jersey

  • New Jersey Medical School Clinical Research Center — Newark

New York

  • Bronx Prevention Center — The Bronx

Other

  • Emavundleni Clinical Research Site — Cape Town

Harare

  • Spilhaus Clinical Research Site — Belgravia

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2014-10
Est. Completion 2017-03-09
Phase Phase 2

Sponsor

PATH

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02165202

The ClinicalTrials.gov registry entry for NCT02165202 describes a study currently listed as completed. It is categorized as Phase 2, 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 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PATH, which has 4 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 Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02165202 reports 4 study locations spanning 4 distinct geographic areas — top geographies include New Jersey, New York, Other. 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 NCT02165202 about?

NCT02165202 is a clinical study titled "Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis". This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.

What is the current status of trial NCT02165202?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2014-10. Estimated completion is 2017-03-09.

What conditions does trial NCT02165202 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02165202?

The interventions under investigation include: Placebo (DRUG), Rilpivirine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02165202?

This trial is sponsored by PATH, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02165202 being conducted?

This trial has 4 study locations across New Jersey, New York, Harare. 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