Completed

Delavirdine Mesylate and Zidovudine Combination for HIV-1 Infected Individuals

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

Delavirdine mesylate

+ Lamivudine

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 14 Years
+27 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

PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo. AS PER AMENDMENT 3/7/96: PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III). AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.

NCT00002124
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.
Design Details

1250 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 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

9 inclusion criteria required to participate
Acceptable medical history, physical exam, EKG, and chest x-ray during screening
CD4 count 200-500 cells/mm3
Consent of parent or guardian if less than 18 years of age
HIV-1 seropositivity
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18 exclusion criteria prevent from participating
Active substance abuse
Active tuberculosis that is sensitive to rifampin
Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose
Any prior ddC, d4T, 3TC, or ddI
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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 88 locations

Univ of Alabama at Birmingham

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

East Bay AIDS Ctr

Berkeley, United States

Peachwood Med Ctr

Clovis, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States
Completed88 Study Centers