Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-04 @ 7:07 PM
Study NCT ID:
NCT00525733
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2007-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects
Status:
COMPLETED
Status Verified Date:
2015-01
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:
None
Brief Summary:
The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest.
Hypotheses:
* Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication.
* Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa.
* Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
Hypotheses:
* Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication.
* Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa.
* Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.
Detailed Description:
* DURATION: Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest.
* SAMPLE SIZE: 36 subjects randomized 2:1 multi-class versus standard antiretroviral therapy.
* POPULATION: Acutely HIV-1-infected, antiretroviral (ARV) drug-naïve (≤ 7 days of ARV treatment at anytime prior to study entry\*) men and women ≥ 18 years of age.
* REGIMEN: At entry subjects will be randomized to one of the following in a 1:2 ratio:
ARM A: FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
ARM B: FTC 200 mg/TDF 300 mg QD + darunavir 800mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
The three primary objectives are:
1. To assess whether a multi-class regimen could completely suppress virus replication in HIV infected individuals based on:
* Plasma HIV-1 RNA levels at 48 weeks
* Ultrasensitive \< 50 copy assay
* 5 copy assay
* 1 copy assay
* Cell associated HIV-1RNA levels at week 48
* Proviral DNA
* Levels at week 48
* Decay rates from week 12 to week 48
2. To determine whether multi-class antiviral therapy results in enhanced immune reconstitution in peripheral blood and gastrointestinal mucosa based on flow and immunohistochemistry.
3. To assess tolerability of multi-class compact antiviral therapy to that of standard compact antiviral therapy.
* SAMPLE SIZE: 36 subjects randomized 2:1 multi-class versus standard antiretroviral therapy.
* POPULATION: Acutely HIV-1-infected, antiretroviral (ARV) drug-naïve (≤ 7 days of ARV treatment at anytime prior to study entry\*) men and women ≥ 18 years of age.
* REGIMEN: At entry subjects will be randomized to one of the following in a 1:2 ratio:
ARM A: FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
ARM B: FTC 200 mg/TDF 300 mg QD + darunavir 800mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
The three primary objectives are:
1. To assess whether a multi-class regimen could completely suppress virus replication in HIV infected individuals based on:
* Plasma HIV-1 RNA levels at 48 weeks
* Ultrasensitive \< 50 copy assay
* 5 copy assay
* 1 copy assay
* Cell associated HIV-1RNA levels at week 48
* Proviral DNA
* Levels at week 48
* Decay rates from week 12 to week 48
2. To determine whether multi-class antiviral therapy results in enhanced immune reconstitution in peripheral blood and gastrointestinal mucosa based on flow and immunohistochemistry.
3. To assess tolerability of multi-class compact antiviral therapy to that of standard compact antiviral therapy.
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?: