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NCT00440947 · ClinicalTrials.gov registry record · Phase 3

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

A Phase 3 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 3
Development phase
515
Enrollment target

NCT00440947 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 515 participants.

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The verdict

NCT00440947, a Phase 3 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 3
Development phase
515 participants
Enrollment target

Study Summary

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

Interventions

  • DRUG Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
  • DRUG Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)

Trial Details

FieldValue
Enrollment Target 515 participants
Start Date 2007-03
Est. Completion 2010-07
Phase Phase 3

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT00440947

The ClinicalTrials.gov registry entry for NCT00440947 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 515 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) is the first listed.

NCT00440947 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00440947 about?

NCT00440947 is a clinical study titled "Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection". This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simpl...

What is the current status of trial NCT00440947?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2007-03. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00440947?

The interventions under investigation include: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) (DRUG), Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) (DRUG).

Who is sponsoring clinical trial NCT00440947?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

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

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.