Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-10 @ 1:40 PM
Study NCT ID:
NCT02470650
Status:
WITHDRAWN
Last Update Posted:
2025-07-30
First Post:
2015-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive
Sponsor:
Juan A. Arnaiz
Organization:
Study Overview
Official Title:
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
Detailed Description:
Secondary objectives:
* patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
* Change in the number of CD4 cells at 48 weeks
* Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
* Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
* Rate of mortality and clinical progression at 48 weeks
* general tolerability and safety: adverse events (AA) and serious AA description
* patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
* Change in the number of CD4 cells at 48 weeks
* Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
* Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
* Rate of mortality and clinical progression at 48 weeks
* general tolerability and safety: adverse events (AA) and serious AA description
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-004820-24 | EUDRACT_NUMBER | None | View |