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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: Completed study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144. The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
- DRUG Raltegravir
- DRUG Emtricitabine/tenofovir disoproxil fumarate
- DRUG Darunavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2009-06 |
| Est. Completion | 2013-06 |
What the finished NCT00851799 record still lists
NCT00851799 is an observational study that tracks outcomes without assigning an intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT00851799 does not publish any study locations in the registry export this page uses.
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.
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