The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
Public ClinicalTrials.gov record NCT00001082. 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 Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil (Bis-POM PMEA) in Prolonging Survival of HIV-Infected Individuals With a CD4+ Cell Count of <= 100/mm3 or With a CD4+ Cell Count Both > 100 and <= 200/mm3 and a Nadir CD4+ Cell Count of <= 50/mm3
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001082
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 505 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- 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
- Dec 1996 (Type not available)
- Primary completion
- Jan 1999 (Actual)
- Completion
- Aug 1999 (Actual)
- Last update posted
- Oct 1, 2013
1996 – 1999
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Community Consortium / UCSF | San Francisco | California | 94110 | — |
| Denver CPCRA / Denver Public Hlth | Denver | Colorado | 80204 | — |
| Washington Reg AIDS Prog / Dept of Infect Dis | Washington D.C. | District of Columbia | 20422 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| AIDS Research Alliance - Chicago | Chicago | Illinois | 60657 | — |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | New Orleans | Louisiana | 70112 | — |
| Wayne State Univ - WSU/DMC / Univ Hlth Ctr | Detroit | Michigan | 48201 | — |
| Henry Ford Hosp | Detroit | Michigan | 48202 | — |
| Southern New Jersey AIDS Cln Trials / Dept of Med | Camden | New Jersey | 08103 | — |
| North Jersey Community Research Initiative | Newark | New Jersey | 07103 | — |
| Partners in Research / New Mexico | Albuquerque | New Mexico | 87131 | — |
| Harlem AIDS Treatment Grp / Harlem Hosp Ctr | New York | New York | 10037 | — |
| The Research and Education Group | Portland | Oregon | 97210 | — |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | — |
| Richmond AIDS Consortium / Div of Infect Diseases | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001082, 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 Oct 1, 2013 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00001082 live on ClinicalTrials.gov.