HIV InfectionsPhase 1NCT00002206
A Study of Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Been Treated With Anti-HIV Drugs
A Phase 1 study testing Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 5 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil. 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
- 45 participants
- Where
- 5 sitesUnited 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
- Patients must have:
- HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot).
- Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment.
- Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry.
- A minimum life expectancy of 12 months.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy.
- Evidence of a gastrointestinal malabsorption syndrome or inability to receive an orally-administered medication.
- A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE:
- Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry.
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- 1. Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit).
- Interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2).
- Aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, chemotherapeutic agents (systemic), systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and other investigational agents.
- 1. Treatment with any HIV protease inhibitor.
- Treatment for more than a total of 2 weeks with any nucleoside or nonnucleoside reverse transcriptase inhibitor antiretroviral agent.
- Ongoing treatment with interferon (alpha, beta, or gamma), interleukins or other immunomodulatory agents, systemic corticosteroids, or any investigational agents except on sponsor's approval within 1 month prior to study entry.
- Evidence of active substance abuse (including alcohol), as determined by the investigator, that would preclude adequate compliance with the protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Univ Clinical Pharmacology
Baltimore, Maryland, 21287
Anderson Clinical Research
New York, New York, 10016
Anderson Clinical Research
Philadelphia, Pennsylvania, 19107
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213
Anderson Clinical Research
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase I/II, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 60 Mg Daily Dose of Adefovir Dipivoxil in HIV-Infected Patients Naive to Anti-Retroviral Therapy
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.
Read the detailed description
This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
- Conditions
- HIV Infections
- Being tested
- Adefovir dipivoxil
- Keywords
- HIV-1, Adenine, Anti-HIV Agents
- 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 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002206
- Sponsor's protocol ID
- 232F
- Other IDs
- GS-97-420
- Status last verified
- Apr 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 Phase I/II, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of 60 Mg Daily Dose of Adefovir Dipivoxil in HIV-Infected Patients Naive to Anti-Retroviral Therapy
- ClinicalTrials.gov ID
- NCT00002206
- Acronym / sponsor ID
- 232F
- Conditions
- HIV Infections
- Keywords
- HIV-1, Adenine, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 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 adefovir dipivoxil once a day for 4 weeks to HIV-infected patients who never have been treated with anti-HIV medicine. This study also examines how the body processes adefovir dipivoxil.
Detailed description
This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.
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 (5 listed)
- HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot).
- Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment.
- Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry.
- A minimum life expectancy of 12 months.
Key exclusion criteria (13 listed)
- Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy.
- Evidence of a gastrointestinal malabsorption syndrome or inability to receive an orally-administered medication.
- A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE:
- Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry.
- 1. Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit).
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.
5 sites 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 5 sites 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 5 inclusion and 13 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 5 sites 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.