Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00389311 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT00389311: Completed Early Phase 1 study, sponsored by Johns Hopkins University.
NCT00389311 is a Early Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00389311, a Early Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.
Interventions
- DRUG Nonoxynol-9
- DRUG Normosol-R
- PROCEDURE Gastrointestinal instrumentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-06 |
| Phase | Early Phase 1 |
What the finished NCT00389311 record still lists
NCT00389311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Nonoxynol-9 is the first listed.
NCT00389311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00389311 about?
NCT00389311 is a clinical study titled "A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides". The purpose of this study is to determine if detectable changes in permeability of the lining of the colon are caused by either application of HIV microbicide gels or medical procedures, such as flexible sigmoidoscopy.
What is the current status of trial NCT00389311?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2007-04. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00389311?
The interventions under investigation include: Nonoxynol-9 (DRUG), Normosol-R (DRUG), Gastrointestinal instrumentation (PROCEDURE).
Who is sponsoring clinical trial NCT00389311?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00389311's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
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