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NCT00851799 · ClinicalTrials.gov registry record

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

A clinical trial, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

Completed
Registry status
334
Enrollment target

NCT00851799 is a clinical trial that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 334 participants.

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The verdict

NCT00851799 has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.

COMPLETED
Registry status
334 participants
Enrollment target

Study Summary

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called combination antiretroviral therapy, cART). Since the introduction of cART, morbidity and mortality among HIV-infected patients has been dramatically reduced. However, metabolic, skeletal, and cardiovascular diseases have been increasingly reported among HIV-infected patients and may be attributable, in part, to the direct effects of cART. Much of our understanding of the development of these diseases, risk factors, and consequences of these disorders has been derived from clinical studies of HIV-infected persons receiving older antiretroviral agents. A5260s was designed to examine the contributions of HIV-disease related factors and impact of newer antiretroviral drugs on the development of metabolic (such as blood vessels, blood sugar, cholesterol), skeletal, and cardiovascular diseases in people who have never received anti-HIV therapy. A5260s is a prospective substudy of a phase III randomized clinical trial A5257 (see ClinicalTrials.gov identifier: NCT00811954). A5257 was designed to look at different combinations of anti-HIV drugs that do not contain the medication efavirenz (EFV) and how well these drug combinations work to decrease the amount of HIV in the blood and to allow immune system recovery in people who have never received anti-HIV therapy. A5257 also examined drug tolerability and safety for the various drug combinations.

Interventions

  • DRUG Ritonavir
  • DRUG Atazanavir
  • DRUG Raltegravir
  • DRUG Emtricitabine/tenofovir disoproxil fumarate
  • DRUG Darunavir

Trial Details

FieldValue
Enrollment Target 334 participants
Start Date 2009-06
Est. Completion 2013-06

What the Registry Record Tells You About NCT00851799

The ClinicalTrials.gov registry entry for NCT00851799 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 334 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.

NCT00851799 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00851799 about?

NCT00851799 is a clinical study titled "Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters". The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV-infected people who have never received anti-HIV therapy be treated with a triple drug regimen (commonly called combination antiretroviral therapy, cART). Since the introduction of cART, morbidity and mortality amon...

What is the current status of trial NCT00851799?

This trial is currently completed. The enrollment target is 334 participants. The study started on 2009-06. Estimated completion is 2013-06.

What interventions are being tested in trial NCT00851799?

The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Raltegravir (DRUG), Emtricitabine/tenofovir disoproxil fumarate (DRUG), Darunavir (DRUG).

Who is sponsoring clinical trial NCT00851799?

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.

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.