HIV InfectionsPhase 1NCT00002403
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
A Phase 1 study testing Zintevir in people with HIV Infections, run by Aronex Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients. Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Zintevir
- How many people
- 12 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive, but do not have any symptoms of HIV infection.
- Have a CD4 count greater than 200 cells/mm3.
- Have a viral load (level of HIV in the body) greater than 4,000 copies/ml.
- Are at least 18 years old.
Who cannot join
- You will not be eligible for this study if you:
- Tend to have abnormal bleeding or other blood problems.
- Have an active AIDS-defining illness.
- Have a history of serious disease or illness.
- Abuse alcohol or drugs.
- Have received certain medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornell AIDS Clinical Trials Unit
New York, New York, 10021
About this study
Official title: A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients
The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients.
Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.
Read the detailed description
Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus.
In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.
- Conditions
- HIV Infections
- Being tested
- Zintevir
- Keywords
- HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZintevirDrug
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.
- 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
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Aronex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002403
- Sponsor's protocol ID
- 290A
- Other IDs
- UNAP 3, AR177-003
- 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 Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients
- ClinicalTrials.gov ID
- NCT00002403
- Acronym / sponsor ID
- 290A
- Conditions
- HIV Infections
- Keywords
- HIV-1, Dose-Response Relationship, Drug, HIV Integrase Inhibitors, HIV Integrase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Aronex PharmaceuticalsIndustry (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 zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients.
Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.
Detailed description
Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus.
In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive, but do not have any symptoms of HIV infection.
- Have a CD4 count greater than 200 cells/mm3.
- Have a viral load (level of HIV in the body) greater than 4,000 copies/ml.
- Are at least 18 years old.
Key exclusion criteria (6 listed)
- Tend to have abnormal bleeding or other blood problems.
- Have an active AIDS-defining illness.
- Have a history of serious disease or illness.
- Abuse alcohol or drugs.
- Have received certain medications.
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 |
|---|---|---|
| Zintevir | 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 Zintevir in people with HIV Infections, run by Aronex Pharmaceuticals 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 5 inclusion and 6 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.