HIV InfectionsPhase 1NCT00002346
The Safety and Effectiveness of Bis-POM PMEA 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, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients. 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
- 36 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:
- Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.
- Patients must have:
- HIV seropositivity.
- CD4 count >= 100 cells/mm3.
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- p24 antigen (immune-complex dissociated) >= 50 pg/ml.
- Life expectancy of at least 6 months.
- Prior Medication:
- Allowed:
- Prior prophylaxis with 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 infection (other than HIV infection) requiring parenteral antibiotic therapy.
- Malignancy other than cutaneous Kaposi's sarcoma.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Gastrointestinal malabsorption syndrome.
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- Inability to take oral medication.
- Concurrent Medication:
- Excluded:
- Any parenteral antibiotic therapy.
- Diuretics.
- Amphotericin B.
- Didanosine (ddI).
- Fluconazole.
- Foscarnet.
- Ganciclovir.
- Interferon-alpha.
- Interferon-beta.
- Isoniazid.
- Aminoglycoside antibiotics.
- Ketoconazole (topical allowed).
- Itraconazole.
- Rifabutin.
- Rifampin.
- Stavudine (d4T).
- Zalcitabine (ddC).
- Zidovudine (AZT).
- Lamivudine (3TC).
- Any investigational agents (except with sponsor approval).
- Systemic therapy for Kaposi's sarcoma.
- Patients with the following prior condition are excluded:
- History of lactose intolerance.
- Prior Medication:
- Excluded within 2 weeks prior to study entry:
- Any parenteral antibiotic therapy.
- Diuretics.
- Amphotericin B.
- Didanosine (ddI).
- Fluconazole.
- Foscarnet.
- Ganciclovir.
- Interferon-alpha.
- Interferon-beta.
- Isoniazid.
- Aminoglycoside antibiotics.
- Ketoconazole (topical allowed).
- Itraconazole.
- Rifabutin.
- Rifampin.
- Stavudine (d4T).
- Zalcitabine (ddC).
- Zidovudine (AZT).
- Lamivudine (3TC).
- Any investigational agents (except with sponsor approval).
- Excluded within 4 weeks prior to study entry:
- Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients
To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
Read the detailed description
Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.
- 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
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002346
- Sponsor's protocol ID
- 232B
- Other IDs
- GS-93-402
- Status last verified
- Mar 1995
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.
PubMed 11364103
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 Phase I/II Study of Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) and Placebo in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002346
- Acronym / sponsor ID
- 232B
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Adenine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 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, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.
Detailed description
Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.
- HIV seropositivity.
- CD4 count >= 100 cells/mm3.
- p24 antigen (immune-complex dissociated) >= 50 pg/ml.
- Life expectancy of at least 6 months.
Key exclusion criteria (56 listed)
- Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
- Malignancy other than cutaneous Kaposi's sarcoma.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Gastrointestinal malabsorption syndrome.
- Inability to take oral medication.
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 11364103James JS. GS 840 (adefovir dipivoxil): broad-spectrum antiviral trial, CD4 count under 100. AIDS Treat News. 1997 Feb 7;(No 264):4-5.
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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.
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 56 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 NCT00002346, 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.