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NCT01400412 · ClinicalTrials.gov registry record · Phase 2

Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

A Phase 2 study of HIV-1-infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
Phase 2
Development phase
262
Enrollment target
20
Study locations

NCT01400412 is a Phase 2 study of HIV-1-infection that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 262 participants, below the 348-participant average among 71 other HIV-1-infection trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01400412, a Phase 2 study of HIV-1-infection, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
Phase 2
Development phase
262 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.

Conditions Studied

HIV-1-infection

Interventions

  • DRUG Ritonavir
  • DRUG Darunavir
  • DRUG Tenofovir disoproxil fumarate
  • DRUG Emtricitabine
  • DRUG Placebo for Tenofovir disoproxil fumarate

Study Locations (20)

California

  • University of Southern California (1201) - Los Angeles
  • UCLA CARE Center CRS (601) - Los Angeles
  • Ucsd, Avrc Crs (701) - San Diego
  • Ucsf Aids Crs (801) - San Francisco

Colorado

  • University of Colorado Hospital CRS (6101) - Aurora
  • University of Colorado Denver ATN CRS (33022) - Denver

District of Columbia

  • Georgetown University CRS (GU CRS) (1008) - Washington D.C.
  • Children's National Med. Ctr. ATN CRS (33003) - Washington D.C.

Florida

  • Univ. of Miami AIDS CRS (901) - Miami
  • Univ. of South Florida (USF) College of Medicine ATN CRS (33001) - Tampa

Illinois

  • Northwestern University CRS (2701) - Chicago
  • Rush Univ. Med. Ctr. ACTG CRS (2702) - Chicago

Maryland

  • IHV Baltimore Treatment CRS (4651) - Baltimore
  • 201 Johns Hopkins University CRS - Baltimore

Massachusetts

  • Massachusetts General Hospital ACTG CRS (101) - Boston
  • Brigham and Women's Hosp. ACTG CRS (107) - Boston

Alabama

  • 31788 Alabama CRS - Birmingham

Trial Details

FieldValue
Enrollment Target 262 participants
Start Date 2012-01-17
Est. Completion 2014-06-30
Phase Phase 2

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

45 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01400412

The ClinicalTrials.gov registry entry for NCT01400412 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 348-participant average among 71 other HIV-1-infection trials with a reported enrollment target (25% lower). The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.

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

NCT01400412 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Colorado, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01400412 about?

NCT01400412 is a clinical study titled "Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen". The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the follo...

What is the current status of trial NCT01400412?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2012-01-17. Estimated completion is 2014-06-30.

What conditions does trial NCT01400412 study?

This clinical trial studies the following conditions: HIV-1-infection.

What interventions are being tested in trial NCT01400412?

The interventions under investigation include: Ritonavir (DRUG), Darunavir (DRUG), Tenofovir disoproxil fumarate (DRUG), Emtricitabine (DRUG), Placebo for Tenofovir disoproxil fumarate (DRUG).

Who is sponsoring clinical trial NCT01400412?

This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01400412 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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 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.