Completed

Pharmacokinetics, Safety, and Tolerance of Oral U-90152 in HIV-1 Infected Patients on Stable AZT Therapy

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What is being tested

Delavirdine mesylate

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

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

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPharmacia and Upjohn
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on evaluating a drug called delavirdine mesylate (U-90152) in combination with zidovudine (AZT) for HIV-1 positive individuals who are asymptomatic and currently on a stable dose of AZT. The goal is to understand the safety, tolerance, and how the body processes the drug when given multiple doses orally. The study aims to find the optimum dose of U-90152 that works well with standard AZT therapy and to see if there are any interactions between these two drugs. It also aims to find the maximum tolerated dose of U-90152 for HIV-1 positive patients already on stable AZT therapy. Lastly, the study will compare how the drug is processed in HIV-1 positive men and women.

NCT00002312
Principal SponsorPharmacia and Upjohn
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.

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

6 inclusion criteria required to participate
Ability to have blood samples drawn
Ability to swallow numerous tablets without difficulty
CD4 count 200 - 500 cells/mm3
HIV-1 infection
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12 exclusion criteria prevent from participating
Acute medical problems, including opportunistic infections (such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, CMV) and nonopportunistic diseases (liver and renal disease, orthostatic hypotension, hypertension, progressive multifocal leukoencephalopathy, lymphoma, Kaposi's sarcoma, or other malignancy)
Antiretroviral agents (other than AZT) or immunomodulating agents within 15 days prior to study entry
Antiretroviral agents other than AZT
Any investigational medication within 15 days prior to study entry. Unwilling to comply with safer sex practices. Active substance abuse. Alcohol consumption during the inpatient pharmacokinetic portion of the study
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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

Bronson Methodist Hosp / Upjohn Research Clinic

Kalamazoo, United StatesOpen Bronson Methodist Hosp / Upjohn Research Clinic in Google Maps
CompletedOne Study Center