Completed

Delavirdine Mesylate and Didanosine Combination for HIV-1 Treatment in Patients with CD4 Counts of <= 300/mm3

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

Delavirdine mesylate

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 14 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
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 HIV-1 infected individuals who have CD4 counts of less than or equal to 300/mm3. The main goal is to evaluate the safety and effectiveness of a drug combination involving Delavirdine Mesylate (U-90152S) and Didanosine (ddI), compared to using Didanosine (ddI) alone. This research is important as it aims to find a better treatment option for HIV-positive patients, potentially improving their quality of life and addressing the challenges associated with current treatments. During this trial, participants are randomly assigned to two groups. One group receives a combination of Delavirdine Mesylate (U-90152S) and Didanosine (ddI), while the other group receives only Didanosine (ddI). The study measures the body's response to these treatments, looking at how well the drugs work, how they are processed in the body, and any potential side effects. This helps researchers understand the safety and effectiveness of the drug combination compared to the single drug therapy.

NCT00002123
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 14 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 DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

8 inclusion criteria required to participate
AZT therapy at some time prior to screening
Acceptable medical history, physical exam, EKG, and chest x-ray during screening
CD4 count <= 300 cells/mm3
Consent of parent or guardian if less than 18 years of age
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16 exclusion criteria prevent from participating
Active tuberculosis that is sensitive to rifampin
Any prior ddC, d4T, or 3TC
Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose
Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
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 84 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

East Bay AIDS Ctr

Berkeley, United States

California Med Research Group

Fresno, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States
Completed84 Study Centers