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NCT00711009 · ClinicalTrials.gov registry record · Phase 3

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

A Phase 3 study, sponsored by Abbott.

Completed
Registry status
Phase 3
Development phase
206
Enrollment target

NCT00711009: Completed Phase 3 study, sponsored by Abbott.

NCT00711009 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00711009, a Phase 3 study, has completed, sponsored by Abbott.

COMPLETED
Registry status
Phase 3
Development phase
206 participants
Enrollment target

Study Summary

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Primary Outcome

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or d

Interventions

  • DRUG lopinavir/ritonavir (LPV/r)
  • DRUG emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
  • DRUG raltegravir (RAL)

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2008-07
Est. Completion 2010-10
Phase Phase 3
Abbott

181 total trials

What the finished NCT00711009 record still lists

NCT00711009 is an interventional study that assigns participants to a tested intervention. The registered 206 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 (73% lower).

The record links to 0 conditions, and to 3 interventions - of which lopinavir/ritonavir (LPV/r) is the first listed.

NCT00711009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00711009 about?

NCT00711009 is a clinical study titled "Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)". The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1...

What is the current status of trial NCT00711009?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2008-07. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00711009?

The interventions under investigation include: lopinavir/ritonavir (LPV/r) (DRUG), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (DRUG), raltegravir (RAL) (DRUG).

Who is sponsoring clinical trial NCT00711009?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00711009's enrollment target sits among peer trials

206 1347th of 2000 higher than 651 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 NCT00711009, the US trial registry maintained by the National Library of Medicine. NCT00711009 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.