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The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
NCT00001082 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 505 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00001082 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Michigan, New Jersey, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00001082?
The interventions under investigation include: Levocarnitine (DRUG), Adefovir dipivoxil (DRUG), Adefovir dipivoxil placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00001082?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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