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
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1996
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.
Drug: Delavirdine mesylate
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||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
|Ages Eligible for Study:
||14 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.
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:
- History of pancreatitis within the past 2 years.
- History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance.
- History of grade 2 or worse peripheral neuropathy.
- Intolerance to ddI in previous treated patients.
- More than 4 months total of prior ddI.
- Any prior ddC, d4T, or 3TC.
- Prior nonnucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA.
- Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose.
- Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines.
- Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose.
- Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose.
- AZT therapy at some time prior to screening. Active substance abuse.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002123
Pharmacia and Upjohn
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Cox SR, Edge-Padbury BA, Carberry PA, Wathen LK. Delavirdine (DLV) + didanosine (ddI) combination therapy has sustained surrogate marker response in advanced HIV-1 population. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2016
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors