Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters
Public ClinicalTrials.gov record NCT00851799. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Substudy of A5257
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00851799
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 334 participants
Conditions and interventions
Conditions
Interventions
- Emtricitabine/tenofovir disoproxil fumarate Drug
- Ritonavir Drug
- Atazanavir Drug
- Raltegravir Drug
- Darunavir Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2009 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Jun 2013 (Actual)
- Last update posted
- Jan 13, 2016
2009 – 2013
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC CRS | Los Angeles | California | 90033 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90035 | — |
| Ucsf Aids Crs | San Francisco | California | 94110 | — |
| Harbor - UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | — |
| The Ponce de Leon Center | Atlanta | Georgia | 30308 | — |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | — |
| Rush University Medical Center (2702) | Chicago | Illinois | 60612 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Brigham and Women's Hosp. ACTG CRS | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| Washington University CRS (2101) | St Louis | Missouri | 63110 | — |
| New Jersey Medical School- Adult Clinical Research Ctr. CRS | Newark | New Jersey | 07103 | — |
| NY Univ. HIV/AIDS CRS (401) | New York | New York | 10016 | — |
| AIDS Care CRS | Rochester | New York | 14607 | — |
| University of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 27514 | — |
| Duke Univ. Med. Ctr. Adult CRS (1601) | Durham | North Carolina | 27710 | — |
| University of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| Metro Health CRS | Cleveland | Ohio | 44109 | — |
| The Ohio State University AIDS CRS (2301) | Colombus | Ohio | 43210 | — |
| Pitt CRS | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37232 | — |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | — |
| University of Washington AIDS CRS (1401) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00851799, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2016 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00851799 live on ClinicalTrials.gov.