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NCT00525733 · ClinicalTrials.gov registry record · NA
Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)
A NA study, sponsored by Rockefeller University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT00525733 is a NA study that has completed, run by Rockefeller University. The registered enrollment target is 40 participants.
The verdict
NCT00525733, a NA study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Maraviroc
- DRUG Raltegravir
- DRUG darunavir 800 mg
- DRUG FTC 200 mg/TDF 300mg
- DRUG Ritonavir 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525733
The ClinicalTrials.gov registry entry for NCT00525733 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Maraviroc is the first listed.
NCT00525733 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525733 about?
NCT00525733 is a clinical study titled "Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)". 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-infe...
What is the current status of trial NCT00525733?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2007-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00525733?
The interventions under investigation include: Maraviroc (DRUG), Raltegravir (DRUG), darunavir 800 mg (DRUG), FTC 200 mg/TDF 300mg (DRUG), Ritonavir 100 mg (DRUG).
Who is sponsoring clinical trial NCT00525733?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
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