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Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

NCT01400412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2024-10-15

Study results available
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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

  • HIV-1 Infection

Interventions

DRUG

Darunavir

Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.

DRUG

Ritonavir

Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.

DRUG

Tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.

DRUG

Emtricitabine

Emtricitabine was administered orally once a day as one 200 mg capsule.

DRUG

Placebo for Tenofovir disoproxil fumarate

Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.

DRUG

Placebo for Maraviroc

Placebo for maraviroc was administered orally once a day as one tablet.

DRUG

Maraviroc

Maraviroc was administered orally once a day as one 150 mg tablet.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Babafemi Taiwo, MBBS, MD · Northwestern University CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-17
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400412 on ClinicalTrials.gov