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CompletedNCT00002403Updated Jun 24, 2005

Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients

A Phase 1 interventional study of Zintevir in HIV Infections, sponsored by Aronex Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Aronex Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • HIV Infections

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Keywords

  • HIV-1
  • Dose-Response Relationship, Drug
  • HIV Integrase Inhibitors
  • HIV Integrase
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 12 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Aronex Pharmaceuticals is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
12 participants

Interventions

  • DrugZintevir
06

Study locations

1 site
  • Cornell AIDS Clinical Trials Unit
    New York, New York 10021, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00002403
Lead sponsor
Aronex Pharmaceuticals
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 1999. You cannot join it, but the record below documents what was studied.

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