Completed
Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity Evaluation of Zintevir (AR177) in HIV-1 Patients
What is being tested
Zintevir
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorAronex Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorAronex Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
4 inclusion criteria required to participate
Are HIV-positive, but do not have any symptoms of HIV infection
Are at least 18 years old
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
5 exclusion criteria prevent from participating
Abuse alcohol or drugs
Have a history of serious disease or illness
Have an active AIDS-defining illness
Have received certain medications
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Cornell AIDS Clinical Trials Unit
New York, United StatesOpen Cornell AIDS Clinical Trials Unit in Google MapsCompletedOne Study Center