HIV Infection Clinical Trial
Official title:
Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to
rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen
on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among
HIV/HCV-coinfected patient.
Secondary Trial Objective:
1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in
the grade of HS between patients continuing with EFV plus two nucleoside analogs and
those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50
copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV
to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current
regimen.
Primary Objective:
To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to
rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen
on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among
HIV/HCV-coinfected patient.
Secondary Trial Objective:
1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in
the grade of HS between patients continuing with EFV plus two nucleoside analogs and
those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
2. To evaluate the proportion of patients who maintain viral control (HIV RNA < 50
copies/mL) after switching.
Design:
Open-label, randomized clinical trial to evaluate safety (phase IV)
Condition:
HIV and HCV coinfection.
Intervention:
Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV
to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current
regimen.
Study population and sample size HIV-infected patients with concomitant coinfection by HCV,
as shown by detectable plasma HCV RNA, not candidates for therapy against HCV infection
during the 48 week period of the Number of patients to recruit: 96, 48 patients per treatment
group should be recruited.
;
| 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
|
||
| Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
| Completed |
NCT02663869 -
Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
|
||
| Completed |
NCT02846402 -
Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda
|
N/A | |
| Completed |
NCT02659306 -
Metformin Immunotherapy in HIV Infection
|
Phase 1 | |
| Completed |
NCT02921516 -
Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings
|
N/A | |
| 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 |
NCT01852942 -
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
|
Phase 2 | |
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Terminated |
NCT01902186 -
Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir
|
Phase 4 | |
| Completed |
NCT01830595 -
Lactoferrin Treatment in HIV Patients
|
Phase 2 | |
| Completed |
NCT02269605 -
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
|
Phase 1 | |
| 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 | |
| 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 | |
| Active, not recruiting |
NCT02602418 -
Neural Correlates of Working Memory Training for HIV Patients
|
N/A | |
| Completed |
NCT01805427 -
Antiretroviral Therapy and Extreme Weight
|
N/A |