HIV InfectionsNCT00002426
A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
A study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 49 sites in 5 countries.
Trial summary
The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Adefovir dipivoxil
- How many people
- 390 participants
- Where
- 49 sitesin 5 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
- Have a CD4 count of 50 cells/mm3 or more.
- Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
- Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.
Who cannot join
None listed.
Trial locations and contacts
49 sites in 5 countries.
49 sites in 5 countries
United States37 sites
Albany Med College
Albany, New York, 12208
IDC Research Initiative
Altamonte Springs, Florida, 32701
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Georgia Research Associates
Atlanta, Georgia, 30342
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, 21205
Pacific Oaks Research
Beverly Hills, California, 90211
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Community AIDS Resource Inc
Coral Gables, Florida, 33146
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
Univ of Texas Med Branch
Galveston, Texas, 77555
Thomas Street Clinic
Houston, Texas, 77009
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Duval County Health Department
Jacksonville, Florida, 32206
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212
Bentley-Salick Med Practice
New York, New York, 10011
St Luke Roosevelt Hosp
New York, New York, 10011
James Jones MD
New York, New York, 10019
Mount Sinai Med Ctr
New York, New York, 10029
ViRx Inc
Palm Springs, California, 92262
The Research and Education Group
Portland, Oregon, 97210
Miriam Hosp
Providence, Rhode Island, 02906
Roger Williams Med Ctr
Providence, Rhode Island, 02908
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814
Health Positive
Safety Harbor, Florida, 34695
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, 84108
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
Kaiser Foundation Hospital
San Francisco, California, 94118
San Francisco VA Med Ctr
San Francisco, California, 94121
N Touch Research Corp
Seattle, Washington, 98122
Blick Med Associates
Stamford, Connecticut, 06901
Center for Quality Care
Tampa, Florida, 33609
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157
United Kingdom4 sites
Chelsea and Westminster Hosp
London
King's College Hospital
London
Royal Free Hosp
London
Senior Lecturer in GU Medicine
London
Canada3 sites
Centre hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
Sunnybrook Health Science Centre
Toronto, Ontario
St Paul's Hosp
Vancouver, British Columbia
Germany3 sites
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt
Universitatskrankenhaus Eppendorf
Hamburg
Klinikum der Ludwig-Maximilians-Universitaet
München
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml
The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.
Read the detailed description
Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.
- Conditions
- HIV Infections
- Being tested
- Adefovir dipivoxil
- Keywords
- HIV-1, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir dipivoxilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 390 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002426
- Sponsor's protocol ID
- 232K
- Other IDs
- GS-97-415
- Status last verified
- Dec 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml
- ClinicalTrials.gov ID
- NCT00002426
- Acronym / sponsor ID
- 232K
- Conditions
- HIV Infections
- Keywords
- HIV-1, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.
Detailed description
Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
- Have a CD4 count of 50 cells/mm3 or more.
- Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
- Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adefovir dipivoxil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 49 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, United Kingdom, Canada, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.