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NCT00046033 · ClinicalTrials.gov registry record · Phase 2

Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance

A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
118
Enrollment target
6
Study locations

NCT00046033 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 118 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT00046033, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
118 participants
Enrollment target
6
Study locations

Study Summary

The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to taking the standard FDA-approved LPV/r dose. This study will also compare the safety and tolerability of these two types of dosing.

Conditions Studied

Interventions

  • DRUG Ritonavir
  • DRUG Saquinavir
  • DRUG Tenofovir disoproxil fumarate
  • DRUG Amprenavir
  • DRUG Lopinavir/ritonavir

Study Locations (6)

Florida

  • Univ of Miami - Miami

Hawaii

  • Univ of Hawaii - Honolulu

New York

  • NYU/Bellevue - New York

Ohio

  • Case Western Reserve Univ - Cleveland

Pennsylvania

  • Univ of Pittsburgh - Pittsburgh

Texas

  • Univ of Texas, Galveston - Galveston

Trial Details

FieldValue
Enrollment Target 118 participants
Phase Phase 2

What the Registry Record Tells You About NCT00046033

The ClinicalTrials.gov registry entry for NCT00046033 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Ritonavir is the first listed.

NCT00046033 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Florida, Hawaii, New York.

Frequently Asked Questions

What is clinical trial NCT00046033 about?

NCT00046033 is a clinical study titled "Comparing Standard-Dose Versus Adjusted-Dose Lopinavir/Ritonavir Therapy in HIV-Infected Persons With Drug Resistance". The purpose of this study is to see if adjusting the dose of lopinavir/ritonavir (LPV/r) has a better effect on lowering HIV viral load (the amount of HIV in the blood) compared to taking the standard FDA-approved LPV/r dose. This study will also compare the safety and tolerability of these two type...

What is the current status of trial NCT00046033?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants.

What conditions does trial NCT00046033 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00046033?

The interventions under investigation include: Ritonavir (DRUG), Saquinavir (DRUG), Tenofovir disoproxil fumarate (DRUG), Amprenavir (DRUG), Lopinavir/ritonavir (DRUG).

Who is sponsoring clinical trial NCT00046033?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00046033 being conducted?

This trial has 6 study locations across Florida, Hawaii, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.