Completed

Single-Dose and Steady-State Pharmacokinetics/Dynamics Evaluation of 1592U89 and 1144U88-TP in HIV-1 Infected Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Abacavir sulfate

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase. On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.

NCT00002388
Principal SponsorGlaxo Wellcome
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

48 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
Allowed: Prophylaxis for opportunistic infections
CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration
HIV-1 infection
No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition
12 exclusion criteria prevent from participating
Antiretroviral therapy within 2 weeks prior to administration of study drugs
Antiretroviral therapy. NOTE: Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs
Chemotherapeutic agents
Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient
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 3 locations

Evanston Hosp / Clinical Pharmacology Unit

Evanston, United StatesOpen Evanston Hosp / Clinical Pharmacology Unit in Google Maps

Fenway Community Health Ctr / Research Dept

Boston, United States

Albany Med College / Albany Med Ctr Hosp

Albany, United States
Completed3 Study Centers