HIV InfectionsPhase 1NCT00002128
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
A Phase 1 study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 1 site in United States.
Trial summary
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Adefovir dipivoxil
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- Patients must have:
- Documented HIV infection or diagnosis of AIDS.
Show all 11Show fewer
- Life expectancy of at least 3 months.
- Prior Medication:
- Allowed:
- Prior AZT, ddI, or ddC.
- Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Gastrointestinal malabsorption syndrome or inability to receive oral medication.
- Concurrent Medication:
Show all 26Show fewer
- Excluded:
- Diuretics.
- Amphotericin B.
- Aminoglycoside antibiotics.
- Parenteral antibiotics.
- Other nephrotoxic agents.
- Other investigational agents.
- Non-steroidal anti-inflammatory drugs.
- Aspirin.
- Prior Medication:
- Excluded within 2 weeks prior to study entry:
- Diuretics.
- Amphotericin B.
- Aminoglycoside antibiotics.
- Parenteral antibiotics.
- Other nephrotoxic agents.
- Other investigational agents.
- Excluded within 3 days prior to study entry:
- Non-steroidal anti-inflammatory drugs.
- Aspirin. Active substance abuse (including alcohol or drug abuse).
Trial locations and contacts
1 site in 1 country.
About this study
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
Read the detailed description
Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.
- Conditions
- HIV Infections
- Being tested
- Adefovir dipivoxil
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002128
- Sponsor's protocol ID
- 232A
- Other IDs
- GS-93-401
- Status last verified
- Jul 1994
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. doi: 10.1128/AAC.39.11.2401.
PubMed 8585716
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
- Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002128
- Acronym / sponsor ID
- 232A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 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.
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
Detailed description
Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
- Documented HIV infection or diagnosis of AIDS.
- Life expectancy of at least 3 months.
- Prior AZT, ddI, or ddC.
Key exclusion criteria (26 listed)
- Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Gastrointestinal malabsorption syndrome or inability to receive oral medication.
- Diuretics.
- Amphotericin B.
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.
- Background: PubMed 8585716Cundy KC, Barditch-Crovo P, Walker RE, Collier AC, Ebeling D, Toole J, Jaffe HS. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type 1-infected patients. Antimicrob Agents Chemother. 1995 Nov;39(11):2401-5. doi: 10.1128/AAC.39.11.2401.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 1 site in United States.
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 11 inclusion and 26 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 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT00002128, which also lists 1 linked publication.
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.