Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

NCT02322827 | Completed

• 1 other identifier: IN-US-236-1642
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.

Conditions

Acquired Immunodeficiency Syndrome; Human Immunodeficiency Virus Type

Keywords

hiv/aids

Outcome Measures

Primary Outcomes (1)

• Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR

  1 year

Secondary Outcomes (7)

• compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR

  2 years

• Compare proportion of subjects with viral load less than 50 copies/microL

  1year

• Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR

  2 years

• Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR

  2 years

• Compare the absolute CD4 number increase between a STR and a MTR

  1 year

Study Arms (2)

single tablet regimen

Subjects whose most recent antiretroviral therapy consist of a single tablet regimen

multiple tablet regimen

Subjects whose most recent antiretroviral therapy consist of multi tablet regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are HIV infected and taking antiretroviral therapy

You may qualify if:

• Male or Female (gender at birth), age 18 years or older
• Documented HIV-1 infection by western blot or HIV viral load
• Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months
• Patients should have a minimum of 3 office visits

You may not qualify if:

• Patients who were evaluated in the hospital but never came to the clinic

Sponsors & Collaborators

• Olayemi Osiyemi MD: lead

Study Sites (1)

Triple O Research Institute PA

West Palm Beach, Florida, 33401, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Olayemi Osiyemi, M.D.

  Triple O Research Institute PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 23, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

US (1)