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NCT00001082 · ClinicalTrials.gov registry record · Phase 3
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
A Phase 3 study of HIV Infections and Cytomegalovirus Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 505
- Enrollment target
- 15
- Study locations
NCT00001082 is a Phase 3 study of HIV Infections and Cytomegalovirus Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 505 participants, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (13% higher). The trial reports 15 study locations across 13 states.
The verdict
NCT00001082, a Phase 3 study of HIV Infections and Cytomegalovirus Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 505 participants
- Enrollment target
- 15
- Study locations
Study Summary
To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir dipivoxil in preventing the development of CMV end-organ disease in patients with advanced HIV coinfected with CMV. The optimal treatment for HIV infection and the prevention of CMV disease has not been identified. Currently available antiretroviral therapies are hampered by both significant toxicities and the development of resistance. In addition, agents for preventing CMV disease, such as oral ganciclovir, are complicated by poor bioavailability and decreased compliance secondary to toxicities. Moreover, discordant results have been reported regarding the effectiveness of oral ganciclovir for preventing CMV disease. There is a need for newer agents with anti-HIV and anti-herpesvirus activity that have good pharmacokinetic and safety profiles and that will be well tolerated by patients. Adefovir dipivoxil is an oral pro-drug of PMEA, a nucleoside analog with activity against a broad spectrum of retroviruses and herpesviruses, including important human pathogens, such as HIV-1, HIV-2 and CMV. Due to its anti-HIV and anti-herpesvirus activity, adefovir dipivoxil may be able to decrease the incidence of opportunistic herpesvirus infections and prolong survival in patients with advanced HIV infection.
Conditions Studied
Interventions
- DRUG Levocarnitine
- DRUG Adefovir dipivoxil
- DRUG Adefovir dipivoxil placebo
Study Locations (15)
Michigan
- Wayne State Univ - WSU/DMC / Univ Hlth Ctr - Detroit
- Henry Ford Hosp - Detroit
New Jersey
- Southern New Jersey AIDS Cln Trials / Dept of Med - Camden
- North Jersey Community Research Initiative - Newark
California
- Community Consortium / UCSF - San Francisco
Colorado
- Denver CPCRA / Denver Public Hlth - Denver
District of Columbia
- Washington Reg AIDS Prog / Dept of Infect Dis - Washington D.C.
Georgia
- AIDS Research Consortium of Atlanta - Atlanta
Illinois
- AIDS Research Alliance - Chicago - Chicago
Louisiana
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 1996-12 |
| Est. Completion | 1999-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001082
The ClinicalTrials.gov registry entry for NCT00001082 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 505 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (13% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Levocarnitine is the first listed.
NCT00001082 reports 15 study locations spanning 13 distinct geographic areas - top geographies include Michigan, New Jersey, California.
Frequently Asked Questions
What is clinical trial NCT00001082 about?
NCT00001082 is a clinical study titled "The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients". To evaluate the safety and efficacy of adefovir dipivoxil in prolonging survival of patients with advanced HIV disease. In CMV prophylaxis substudy: To evaluate the efficacy of adefovir dipivoxil in preventing the development of CMV end-organ disease in patients with advanced HIV coinfected with CMV...
What is the current status of trial NCT00001082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 505 participants. The study started on 1996-12. Estimated completion is 1999-08.
What conditions does trial NCT00001082 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Infections.
What interventions are being tested in trial NCT00001082?
The interventions under investigation include: Levocarnitine (DRUG), Adefovir dipivoxil (DRUG), Adefovir dipivoxil placebo (DRUG).
Who is sponsoring clinical trial NCT00001082?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001082 being conducted?
This trial has 15 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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