Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00002184 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00002184 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 120 participants.
The verdict
NCT00002184, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or stavudine (Group 2) vs. the combination of adefovir dipivoxil and saquinavir SGC plus either zidovudine, lamivudine, or stavudine (Group 3) in HIV-infected patients with prior nucleoside reverse transcriptase inhibitor therapy but no prior exposure to protease inhibitors who have CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\<500 copies/ml) at 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
Interventions
- DRUG Lamivudine
- DRUG Levocarnitine
- DRUG Nelfinavir mesylate
- DRUG Saquinavir
- DRUG Adefovir dipivoxil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002184
The ClinicalTrials.gov registry entry for NCT00002184 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Lamivudine is the first listed.
NCT00002184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002184 about?
NCT00002184 is a clinical study titled "A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient". To evaluate the safety and tolerance of the combination of adefovir dipivoxil at two comparative doses and nelfinavir plus saquinavir SGC administered orally (Group 1) vs. the combination of adefovir dipivoxil and nelfinavir plus either zidovudine, lamivudine, or stavudine (Group 2) vs. the combinat...
What is the current status of trial NCT00002184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants.
What interventions are being tested in trial NCT00002184?
The interventions under investigation include: Lamivudine (DRUG), Levocarnitine (DRUG), Nelfinavir mesylate (DRUG), Saquinavir (DRUG), Adefovir dipivoxil (DRUG).
Who is sponsoring clinical trial NCT00002184?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.