HIV Infection Clinical Trial
Official title:
Extreme Weights and Antiretroviral Therapy Individual Concentrations
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse
Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according
to the body weight or body composition and therapeutic monitoring may be necessary in
overweight HIV patients.
The investigators aim at measuring the individual trough concentrations of interest [at
steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.
Our primary endpoint is the individual trough concentrations of interest at steady state for
NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between
patients <25kg/m2 and patients<25kg/m2
Secondary endpoints:
- Occurrence of virologic failure
- Occurrence of clinical/biological adverse events
- Percentage of patients with concentration within the therapeutic range
- Body composition Secondary outcome measures: comparison of the occurrence of virologic
failure, occurrence or adverse event, patients with concentration within the
therapeutic range between groups. Correlation between body composition and
concentration.
Methodology, study design:
open-labelled monocentric study.
Sample size:
It will be a descriptive experimental study involving 120 overweight subjects, 120 normal
weight subjects
Inclusion criteria :
- Patients with HIV+
- Patients aged more than 18 years old.
- Patient giving its well-informed and free consent.
Study design :
Plasma concentration was performed during the usual clinical follow-up. Study duration: 12
months Duration for a patient: 1 day Investigating center and participating units: one
center enrolling the patients and the lab performing drug dosages.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02135419 -
Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
|
Phase 3 | |
| Active, not recruiting |
NCT02663856 -
My Smart Age With HIV: Smartphone Self-assessment of Frailty
|
||
| Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
| Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
| Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
| Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
| Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
| Completed |
NCT02564341 -
Targeting Effective Analgesia in Clinics for HIV - Intervention
|
N/A | |
| Active, not recruiting |
NCT02302950 -
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas
|
N/A | |
| Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
| Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
| Completed |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
| Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Completed |
NCT02525146 -
Birmingham Access to Care Study
|
N/A | |
| Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
| Completed |
NCT02118168 -
Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002
|
N/A | |
| Completed |
NCT02527135 -
Text Messaging to Improve HIV Testing Among Young Women in Kenya
|
N/A | |
| Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
| Completed |
NCT01702974 -
Immune Reconstitution in HIV Disease (IREHIV)
|
Phase 2 |