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

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. According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00046033 record still lists

NCT00046033 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (74% lower).

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 lists 6 locations in 6 states (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.

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 NCT00046033's enrollment target sits among peer trials

118 249th of 542 higher than 292 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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Source: ClinicalTrials.gov NCT00046033, the US trial registry maintained by the National Library of Medicine. NCT00046033 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.