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NCT00830804 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
A Phase 2 study of HIV-1 Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 20
- Study locations
NCT00830804: Completed Phase 2 study of HIV-1 Infections, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT00830804 is a Phase 2 study of HIV-1 Infections that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 113 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00830804, a Phase 2 study of HIV-1 Infections, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Primary Outcome
Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in con
Conditions Studied
Interventions
- DRUG Raltegravir
- DRUG Darunavir/Ritonavir
Study Locations (20)
Ohio
- Univ. of Cincinnati CRS - Cincinnati
- Case CRS - Cleveland
- MetroHealth CRS - Cleveland
- The Ohio State Univ. AIDS CRS - Columbus
California
- Stanford CRS - Palo Alto
- Ucsd, Avrc Crs - San Diego
- Ucsf Aids Crs - San Francisco
Massachusetts
- Beth Israel Deaconess Med Center - Boston
- Brigham and Women's Hosp. ACTG CRS - Boston
North Carolina
- Unc Aids Crs - Chapel Hill
- Duke Univ. Med. Ctr. Adult CRS - Durham
Pennsylvania
- Hosp. of the Univ. of Pennsylvania CRS - Philadelphia
- University of Pittsburgh CTU - Pittsburgh
Alabama
- AlabamaTherapeutics CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
District of Columbia
- Georgetown University CRS - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00830804 record still lists
NCT00830804 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% lower).
The record links to 1 condition, with HIV-1 Infections appearing as the primary indexed condition, and to 2 interventions - of which Raltegravir is the first listed.
NCT00830804 names 20 study sites across 12 states, led by Ohio, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00830804 about?
NCT00830804 is a clinical study titled "Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults". The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
What is the current status of trial NCT00830804?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2009-04. Estimated completion is 2010-09.
What conditions does trial NCT00830804 study?
This clinical trial studies the following conditions: HIV-1 Infections.
What interventions are being tested in trial NCT00830804?
The interventions under investigation include: Raltegravir (DRUG), Darunavir/Ritonavir (DRUG).
Who is sponsoring clinical trial NCT00830804?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00830804 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00830804's enrollment target sits among peer trials
113 631st of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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