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A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients.

NCT00002440•Glaxo Wellcome

View on ClinicalTrials.gov

Summary

The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.

Detailed Description

In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Concurrent Medication:
•Allowed:
•Local treatment for Kaposi's sarcoma.
•GM-CSF, G-CSF or erythropoietin.
•Patients must have:
•HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
•CD4+ cell count \>= 100 cells/mm3 within 14 days of study drug administration.
•HIV-1 RNA \>= 5,000 copies/ml within 14 days of study drug administration.
•No active or ongoing AIDS-defining opportunistic infection or disease.
•Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
+3 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with the following conditions or symptoms are excluded:
•Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
•Life-threatening infection or other serious medical condition that may compromise a patient's safety.
•Concurrent Medication:
•Excluded:
•Other investigational agents. NOTE:
•Those available through Treatment IND or expanded access programs are evaluated individually.
•Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
•Agents with documented anti-HIV activity in vitro.
+18 more criteria

Locations (8)

UCSD Treatment Ctr

San Diego, California, United States

Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit

New Haven, Connecticut, United States

Kansas City AIDS Research Consortium

Kansas City, Missouri, United States

NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial

New York, New York, United States

Carolinas Med Ctr

Charlotte, North Carolina, United States

Case Western Reserve Univ / AIDS Clinical Trials Unit

Cleveland, Ohio, United States

Univ of Pittsburgh Med Ctr

Pittsburgh, Pennsylvania, United States

Vanderbilt Univ Med Ctr

Nashville, Tennessee, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Indinavir sulfate

DRUG

Ritonavir

DRUG

Abacavir sulfate

DRUG

Amprenavir

DRUG

Nelfinavir mesylate

DRUG

Saquinavir

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Inclusion Criteria

Exclusion Criteria

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