Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01087814 · ClinicalTrials.gov registry record · Phase 4

Sustiva Levels With Use of a Gel Capsule

A Phase 4 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 4
Development phase
16
Enrollment target

NCT01087814: Completed Phase 4 study, sponsored by University of Minnesota.

NCT01087814 is a Phase 4 study that has completed, run by University of Minnesota. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01087814, a Phase 4 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 4
Development phase
16 participants
Enrollment target

Study Summary

We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

Primary Outcome

Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.

Interventions

  • DRUG Efavirenz
  • DRUG Over-encapsulated efavirenz

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2010-02
Est. Completion 2011-09
Phase Phase 4
University of Minnesota

966 total trials

What the finished NCT01087814 record still lists

NCT01087814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Efavirenz is the first listed.

NCT01087814 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01087814 about?

NCT01087814 is a clinical study titled "Sustiva Levels With Use of a Gel Capsule". We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will g...

What is the current status of trial NCT01087814?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2010-02. Estimated completion is 2011-09.

What interventions are being tested in trial NCT01087814?

The interventions under investigation include: Efavirenz (DRUG), Over-encapsulated efavirenz (DRUG).

Who is sponsoring clinical trial NCT01087814?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01087814's enrollment target sits among peer trials

16 1869th of 2000 higher than 121 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02422641 · 16 participants · Phase 2

    Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

  • NCT02851758 · 16 participants · NA

    Transplantation of Autologously Derived Mitochondria Following Ischemia

  • NCT03291028 · 16 participants

    Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma

  • NCT03425526 · 16 participants · Phase 1

    Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01087814, the US trial registry maintained by the National Library of Medicine. NCT01087814 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.