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A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

NCT00002123•Pharmacia and Upjohn

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.

Eligibility

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Concurrent Medication:
•Allowed:
•AZT.
•Patients must have:
•HIV-1 seropositivity.
•CD4 count \<= 300 cells/mm3.
•No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV).
•Consent of parent or guardian if less than 18 years of age.
•Understanding of potential risk to fetus related to study participation.
•Acceptable medical history, physical exam, EKG, and chest x-ray during screening.
+2 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with the following symptoms or conditions are excluded:
•Active tuberculosis that is sensitive to rifampin.
•Inability to swallow numerous tablets.
•Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy.
•Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine).
•Grade 2 or worse baseline organ function. NOTE:
•Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE:
•Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better.
•Patients with the following prior conditions are excluded:
+15 more criteria

Locations (84)

Univ of Alabama at Birmingham

Birmingham, Alabama, United States

East Bay AIDS Ctr

Berkeley, California, United States

California Med Research Group

Fresno, California, United States

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Los Angeles County / Health Research Assoc / Drew Med Ctr

Los Angeles, California, United States

CARE Ctr / UCLA Med Ctr

Los Angeles, California, United States

UCI Med Ctr

Orange, California, United States

AIDS Community Research Consortium

Redwood City, California, United States

UCD Med Ctr / AIDS and Related Disorders Clinic

Sacramento, California, United States

St Lukes Medical Group

San Diego, California, United States

Key Dates

Last Updated

June 24, 2005

Conditions

HIV Infections

Interventions

Delavirdine mesylate

DRUG

Didanosine

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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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 Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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

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