Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
Public ClinicalTrials.gov record NCT00350272. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Elvucitabine, a novel nucleoside analog, is being studied as a treatment for participants with human immunodeficiency virus (HIV)-1. This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as measured by changes in the participant's HIV-ribonucleic acid (RNA) level and CD4 cell count. The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open-label treatment if the participant's response to treatment meets certain endpoints. The pharmacokinetics of elvucitabine will also be assessed during the study.
Study identification
- NCT ID
- NCT00350272
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2006
- Primary completion
- Jul 31, 2007
- Completion
- Mar 31, 2009
- Last update posted
- Aug 29, 2023
2006 – 2009
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Trial Site | Little Rock | Arkansas | 72207 | — |
| Clinical Trial Site | Long Beach | California | 90813 | — |
| Clinical Trial Site | Los Angeles | California | 90069 | — |
| Clinical Trial Site | Washington D.C. | District of Columbia | 20007 | — |
| Clinical Trial Site | Clearwater | Florida | 33765 | — |
| Clinical Trial Site | Fort Myers | Florida | 33901 | — |
| Clinical Trial Site | Miami | Florida | 33133 | — |
| Clinical Trial Site | Miami | Florida | 33136 | — |
| Clinical Trial Site | Orlando | Florida | 32803 | — |
| Clinical Trial Site | Tampa | Florida | 33602 | — |
| Clinical Trial Site | Tampa | Florida | 33614 | — |
| Clinical Trial Site | West Palm Beach | Florida | 33401 | — |
| Clinical Trial Site | Chicago | Illinois | 60611 | — |
| Clinical Trial Site | Wichita | Kansas | 67214 | — |
| Clinical Trial Site | Washington D.C | Maryland | 20007 | — |
| Clinical Trial Site | Boston | Massachusetts | 02215 | — |
| Clinical Trial Site | Newark | New Jersey | 07102 | — |
| Clinical Trial Site | New York | New York | 10003 | — |
| Clinical Trial Site | Austin | Texas | 75705 | — |
| Clinical Trial Site | Dallas | Texas | 75204 | — |
| Clinical Trial Site | Houston | Texas | 77004 | — |
| Clinical Trial Site | Houston | Texas | 77009 | — |
| Clinical Trial Site | Houston | Texas | 77030 | — |
| Clinical Trial Site | Houston | Texas | 77098 | — |
| Clinical Trial Site | Hampton | Virginia | 23666 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00350272, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2023 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00350272 live on ClinicalTrials.gov.