Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-13 @ 12:45 PM
Study NCT ID:
NCT02770508
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2015-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects
Sponsor:
Fundación Huésped
Organization:
Study Overview
Official Title:
A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANDES
Brief Summary:
The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.
Detailed Description:
Key Inclusion Criteria
1. Documented HIV RNA \>1000 copies/ml
2. Subject naïve to ARV. .
3. Subject has indication to receive an antiretroviral regimen, based on local guidelines.
4. Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception
Key Exclusion Criteria
1. Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test
2. Patient with chronic hepatitis B
3. Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System
4. Required use of disallowed concomitant therapies
5. Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table
Primary Objective
• Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)
1. Documented HIV RNA \>1000 copies/ml
2. Subject naïve to ARV. .
3. Subject has indication to receive an antiretroviral regimen, based on local guidelines.
4. Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception
Key Exclusion Criteria
1. Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test
2. Patient with chronic hepatitis B
3. Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System
4. Required use of disallowed concomitant therapies
5. Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table
Primary Objective
• Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)
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?: