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NCT00884793 · ClinicalTrials.gov registry record · NA

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

A NA study of HIV Infections, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
8
Enrollment target
2
Study locations

NCT00884793: Completed NA study of HIV Infections, sponsored by University of California, San Francisco.

NCT00884793 is a NA study of HIV Infections that has completed, run by University of California, San Francisco. The registered enrollment target is 8 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00884793, a NA study of HIV Infections, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
8 participants
Enrollment target
2
Study locations

Study Summary

The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load \< 50 copies/mL (herein referred to as "suppressed"). We hypothesize that there is ongoing replication in the gut despite suppressive ART and that this replication can be inhibited by the addition of one or two new antiretroviral drugs whose activity affects a distinct part of the viral life cycle. All study participants will have upper and lower endoscopy at baseline (before intensification) and after intensification. These endoscopies will be used to obtain gut tissue and single cells (for CD4+ cells) .

Primary Outcome

Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum

Conditions Studied

HIV Infections

Interventions

  • DRUG raltegravir
  • DRUG Study NNRTI
  • DRUG Study PI

Study Locations (2)

California

  • San Francisco General Hospital - San Francisco
  • San Francisco VA Medical Center (SFVAMC) - San Francisco

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2008-09
Est. Completion 2010-12
Phase NA
University of California, San Francisco

1,713 total trials

What the finished NCT00884793 record still lists

NCT00884793 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (98% lower).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which raltegravir is the first listed.

NCT00884793 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00884793 about?

NCT00884793 is a clinical study titled "Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut". The "PLUS" study is a pilot study to measure the effect of therapy intensification (with raltegravir and optional second agent) on HIV levels in the gut and blood in patients on antiretroviral therapy (ART) with viral load \< 50 copies/mL (herein referred to as "suppressed"). We hypothesize that the...

What is the current status of trial NCT00884793?

This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2008-09. Estimated completion is 2010-12.

What conditions does trial NCT00884793 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00884793?

The interventions under investigation include: raltegravir (DRUG), Study NNRTI (DRUG), Study PI (DRUG).

Who is sponsoring clinical trial NCT00884793?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00884793 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00884793's enrollment target sits among peer trials

8 533rd of 542 higher than 8 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections 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

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Related registry views

Source: ClinicalTrials.gov NCT00884793, the US trial registry maintained by the National Library of Medicine. NCT00884793 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.