HIV InfectionsPhase 1NCT00002115
A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
A Phase 1 study testing Adefovir in people with HIV Infections, run by Gilead Sciences at 1 site in United States.
Trial summary
To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease. 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
- How many people
- 20 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:
- Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.
- Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.
- Patients must have:
- HIV seropositivity.
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- Elevated p24 antigen (> 40 pg/ml).
- Mean CD4 count <= 100 cells/mm3.
- Life expectancy of at least 3 months.
- Prior Medication:
- Allowed:
- Other prior antiretroviral therapy.
- Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Inadequate venous access.
- Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Psychiatric disturbance or illness that may affect compliance.
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- Malignancy other than Kaposi's sarcoma.
- Concurrent Medication:
- Excluded:
- Investigational agents other than stavudine (d4T).
- Interferon-alpha.
- Ganciclovir.
- Foscarnet.
- Diuretics.
- Amphotericin B.
- Aminoglycoside antibiotics.
- Other nephrotoxic agents.
- Acyclovir at doses >= 2 g/day.
- Prior Medication:
- Excluded within 2 weeks prior to study entry:
- Investigational agents other than stavudine (d4T).
- Interferon-alpha.
- Ganciclovir.
- Foscarnet.
- Diuretics.
- Amphotericin B.
- Aminoglycoside antibiotics.
- Other nephrotoxic agents.
- Excluded within 4 weeks prior to study entry:
- Systemic therapy for Kaposi's sarcoma. Substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.
Read the detailed description
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
- Conditions
- HIV Infections
- Being tested
- Adefovir
- Keywords
- Acquired Immunodeficiency Syndrome, Antiviral Agents, Adenine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdefovirDrug
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 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002115
- Sponsor's protocol ID
- 217A
- Other IDs
- GS-92-202
- Status last verified
- Nov 1995
- 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 Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
- ClinicalTrials.gov ID
- NCT00002115
- Acronym / sponsor ID
- 217A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, Antiviral Agents, Adenine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.
Detailed description
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
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 (13 listed)
- Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry.
- Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry.
- HIV seropositivity.
- Elevated p24 antigen (> 40 pg/ml).
- Mean CD4 count <= 100 cells/mm3.
Key exclusion criteria (30 listed)
- Inadequate venous access.
- Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Psychiatric disturbance or illness that may affect compliance.
- Malignancy other than Kaposi's sarcoma.
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 | 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.
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 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 13 inclusion and 30 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?
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.