Completed

A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy

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

Delavirdine mesylate

+ Zidovudine
+ Didanosine
Drug
Who is being recruted

HIV Infections

Over 13 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease. U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease. Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.

Official TitleA Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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
471 patients to be enrolledTotal 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.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

Inclusion Criteria Concurrent Medication: Required: * PCP prophylaxis for patients with CD4 count \<= 200 cells/mm3. Allowed: * Topical antifungal agents. * Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections. * Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis). * Acute or maintenance therapy for toxoplasmosis. * Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection. * rEPO and rG-CSF. * Antibiotics for bacterial infections (except rifampin and rifabutin). * Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone. Concurrent Treatment: Allowed for cutaneous Kaposi's sarcoma: * Localized radiation therapy. * Limited intralesional therapy. Patients must have: * HIV infection. * CD4 count 100 - 500 cells/mm3. * Prior cumulative monotherapy of \<= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma). * Considered to be unlikely to comply with study requirements. Concurrent Medication: Excluded: * Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF). * Rifampin. * Rifabutin. * Terfenadine. * Astemizole. * Loratadine. * Quinidine. * Digitoxin. * Systemic corticosteroids for more than 21 consecutive days. * Foscarnet. * Systemic cytotoxic chemotherapy for a malignancy. Patients with the following prior conditions are excluded: * History of intolerance to AZT at \<= 600 mg/day or ddI at \<= 400 mg/day or discontinuation of either drug for toxicity. * History of intolerance to trifluoperazine or piperazine citrate (per amendment). * History of pancreatitis. * History of grade 2 or worse peripheral neuropathy. * Unexplained temperature \>= 38.5 C on any 7 days within the past 30 days. * Chronic diarrhea on any 15 days during the past 30 days. Prior Medication: Excluded: * Prior foscarnet as induction or maintenance therapy. * Prior U-90152. * Prior ddC or d4T. * Prior AZT/ddI in combination or taken separately at different times. * Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.). * Prior protease inhibitors (although patients from ACTG 282 are eligible). * HIV-1 vaccine within the past 21 days. * Acute treatment for a serious infection or for any opportunistic infection within the past 14 days. Excluded within the past 30 days: * Interferon or interleukin. * Rifampin. * Rifabutin. * Terfenadine. * Astemizole. * Loratadine. * Recombinant EPO or G-CSF. * Hydroxyurea. * SPV-30. * Any other investigational drug. Active drug or alcohol use.



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 32 locations
Suspended
Alabama Therapeutics CRSBirmingham, United StatesSee the location
Suspended
USC CRSLos Angeles, United States
Suspended
Stanford CRSPalo Alto, United States
Suspended
Ucsd, Avrc CrsSan Diego, United States

Completed32 Study Centers