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NCT00135395 · ClinicalTrials.gov registry record · Phase 3

A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
200
Enrollment target

NCT00135395: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT00135395 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00135395, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
200 participants
Enrollment target

Study Summary

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Interventions

  • DRUG Atazanavir+ritonavir
  • DRUG Lopinavir+ritonavir

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2004-05
Est. Completion 2006-02
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00135395 record still lists

NCT00135395 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

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

NCT00135395 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00135395 about?

NCT00135395 is a clinical study titled "A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen". The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

What is the current status of trial NCT00135395?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2004-05. Estimated completion is 2006-02.

What interventions are being tested in trial NCT00135395?

The interventions under investigation include: Atazanavir+ritonavir (DRUG), Lopinavir+ritonavir (DRUG).

Who is sponsoring clinical trial NCT00135395?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00135395's enrollment target sits among peer trials

200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00135395, the US trial registry maintained by the National Library of Medicine. NCT00135395 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.