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NCT00118898 · ClinicalTrials.gov registry record · Phase 3
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
A Phase 3 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,864
- Enrollment target
NCT00118898: Completed Phase 3 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT00118898 is a Phase 3 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 1,864 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00118898, a Phase 3 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,864 participants
- Enrollment target
Study Summary
Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.
Primary Outcome
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or \>=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Interventions
- DRUG Ritonavir
- DRUG Atazanavir
- DRUG Efavirenz
- DRUG Abacavir/Lamivudine
- DRUG Emtricitabine/Tenofovir disoproxil fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,864 participants |
| Start Date | 2005-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
What the finished NCT00118898 record still lists
NCT00118898 is an interventional study that assigns participants to a tested intervention. Its 1,864 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (141% higher).
The record links to 0 conditions, and to 5 interventions - of which Ritonavir is the first listed.
NCT00118898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00118898 about?
NCT00118898 is a clinical study titled "Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults". Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be test...
What is the current status of trial NCT00118898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,864 participants. The study started on 2005-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00118898?
The interventions under investigation include: Ritonavir (DRUG), Atazanavir (DRUG), Efavirenz (DRUG), Abacavir/Lamivudine (DRUG), Emtricitabine/Tenofovir disoproxil fumarate (DRUG).
Who is sponsoring clinical trial NCT00118898?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00118898's enrollment target sits among peer trials
1,864 114th of 2000 higher than 1,887 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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