Examining body composition changes in HIV-infected individuals starting treatment
Observational Study of Cardiometabolic Risk in HIV Infected Subjects After Initiation of Antiretroviral Therapy: the Cleveland Cardiometabolic Cohort
This study looks at how starting HIV treatment affects body changes in people with HIV and how their diet and exercise might play a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03059121 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how body composition changes in individuals with HIV before and after they begin antiretroviral therapy (ART). It aims to explore the relationships between lifestyle factors, such as diet and physical activity, and these changes in body composition. Additionally, the study will assess how alterations in body fat correlate with cardiometabolic indices, including endothelial function and coronary calcium scoring. Participants will undergo dual-energy X-ray absorptiometry to measure body composition.
Who should consider this trial
Good fit: Ideal candidates are HIV-infected individuals who are not currently on antiretroviral therapy and are planning to start treatment.
Not a fit: Patients who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing body composition and cardiometabolic health in HIV-infected patients undergoing treatment.
How similar studies have performed: While there have been studies on body composition in HIV, this specific observational approach focusing on lifestyle factors and cardiometabolic indices is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test * Provides written informed consent and is capable of reading and comprehending the informed consent * Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped \>6 months prior to study entry * Is planning on starting antiretroviral therapy as part of routine clinic care Exclusion Criteria: * Pregnancy or lactation
Where this trial is running
Cleveland, Ohio
- University Hospitals Case Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Grace McComsey, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Danielle Labbato, BSN
- Email: danielle.labbato@uhhospitals.org
- Phone: 216-844-2739
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.