HIV Infections Clinical Trial
Official title:
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
| NCT number | NCT00002123 |
| Other study ID # | 228A |
| Secondary ID | M/3331/0017 |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 2, 1999 |
| Last updated | June 23, 2005 |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years and older |
| Eligibility |
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. NOTE: - Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted. 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: - 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. Prior Medication: Excluded: - 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. Required: - AZT therapy at some time prior to screening. Active substance abuse. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | UPR School of Medicine | San Juan | |
| United States | Albany Med College | Albany | New York |
| United States | Univ of Michigan Hospitals and Health Ctrs | Ann Arbor | Michigan |
| United States | Infectious Disease Rsch Consortium of GA / SE Clin Resources | Atlanta | Georgia |
| United States | Central Texas Med Foundation | Austin | Texas |
| United States | Univ of Maryland at Baltimore | Baltimore | Maryland |
| United States | East Bay AIDS Ctr | Berkeley | California |
| United States | Univ of Alabama at Birmingham | Birmingham | Alabama |
| United States | Boston City Hosp / FGH-1 | Boston | Massachusetts |
| United States | Brigham and Women's Hosp | Boston | Massachusetts |
| United States | Massachusetts Gen Hosp | Boston | Massachusetts |
| United States | New England Deaconess Hosp | Boston | Massachusetts |
| United States | SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York |
| United States | Med Ctr of Vermont Hosp | Burlington | Vermont |
| United States | Univ of North Carolina School of Medicine | Chapel Hill | North Carolina |
| United States | Med Univ of South Carolina | Charleston | South Carolina |
| United States | Carolinas Med Ctr | Charlotte | North Carolina |
| United States | Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois |
| United States | Univ of Illinois | Chicago | Illinois |
| United States | Univ of Cincinnati / Holmes Hosp | Cincinnati | Ohio |
| United States | Dallas Veterans Administration Med Ctr | Dallas | Texas |
| United States | Univ Hosp / Univ of Colorado Health Sci Ctr | Denver | Colorado |
| United States | Harper Hosp | Detroit | Michigan |
| United States | Henry Ford Hosp | Detroit | Michigan |
| United States | Duke Univ Med Ctr | Durham | North Carolina |
| United States | California Med Research Group | Fresno | California |
| United States | Pennsylvania State Univ / Hershey Med Ctr | Hershey | Pennsylvania |
| United States | Houston Veterans Administration Med Ctr | Houston | Texas |
| United States | Park Plaza Hosp | Houston | Texas |
| United States | Univ TX Health Science Ctr | Houston | Texas |
| United States | Indiana Univ Infectious Disease Research Clinic | Indianapolis | Indiana |
| United States | Univ of Iowa | Iowa City | Iowa |
| United States | Univ of Kansas School of Medicine / Univ Hosp | Kansas City | Kansas |
| United States | Univ of Missouri at Kansas City School of Medicine | Kansas City | Missouri |
| United States | Univ of Kentucky Med Ctr / Chandler Med Ctr | Lexington | Kentucky |
| United States | CARE Ctr / UCLA Med Ctr | Los Angeles | 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 | Univ of Wisconsin | Madison | Wisconsin |
| United States | Univ of Tennessee | Memphis | Tennessee |
| United States | Univ of Miami School of Medicine | Miami | Florida |
| United States | Vanderbilt Univ | Nashville | Tennessee |
| United States | Jersey Shore Med Ctr | Neptune | New Jersey |
| United States | Tulane Univ Med School | New Orleans | Louisiana |
| United States | Beth Israel Med Ctr | New York | New York |
| United States | Community Research Initiative on AIDS | New York | New York |
| United States | Mount Sinai Med Ctr | New York | New York |
| United States | New York Hosp - Cornell Med Ctr | New York | New York |
| United States | Saint Vincent's Hosp and Med Ctr | New York | New York |
| United States | Univ of Nebraska Med Ctr / HIV Clinic | Omaha | Nebraska |
| United States | UCI Med Ctr | Orange | California |
| United States | Caremark Inc | Palm Beach Gardens | Florida |
| United States | Mem Hosp of Rhode Island | Pawtucket | Rhode Island |
| United States | Buckley Braffman Stern Med Associates | Philadelphia | Pennsylvania |
| United States | Children's Hosp of Philadelphia | Philadelphia | Pennsylvania |
| United States | Oncology and Hematology Association | Philadelphia | Pennsylvania |
| United States | Univ of Pennsylvania / HIV Clinic | Philadelphia | Pennsylvania |
| United States | Univ of Pittsburgh Med School | Pittsburgh | Pennsylvania |
| United States | AIDS Consultation Service / Maine Med Ctr | Portland | Maine |
| United States | Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon |
| United States | AIDS Community Research Consortium | Redwood City | California |
| United States | Richmond AIDS Consortium | Richmond | Virginia |
| United States | Community Health Network | Rochester | New York |
| United States | Univ of Rochester Med Ctr | Rochester | New York |
| United States | UCD Med Ctr / AIDS and Related Disorders Clinic | Sacramento | California |
| United States | Univ TX San Antonio Health Science Ctr | San Antonio | Texas |
| United States | St Lukes Medical Group | San Diego | California |
| United States | UCSD / Ctr for Special Immunology | San Diego | California |
| United States | Davies Med Ctr | San Francisco | California |
| United States | Saint Francis Mem Hosp | San Francisco | California |
| United States | ViRx Inc | San Francisco | California |
| United States | Univ of Washington | Seattle | Washington |
| United States | Baystate Med Ctr of Springfield | Springfield | Massachusetts |
| United States | Washington Univ | St. Louis | Missouri |
| United States | St Paul Ramsey Med Ctr / HIV Program Office | St. Paul | Minnesota |
| United States | SUNY / Health Sciences Ctr at Stony Brook | Stony Brook | New York |
| United States | Infectious Disease Research Institute Inc | Tampa | Florida |
| United States | Shared Med Research Foundation | Tarzana | California |
| United States | Harbor - UCLA Med Ctr | Torrance | California |
| United States | New York Med College / Westchester County Med Ctr | Valhalla | New York |
| United States | George Washington Univ Med Ctr | Washington | District of Columbia |
| United States | Georgetown Univ Med Ctr | Washington | District of Columbia |
| United States | Univ of Kansas School of Medicine | Wichita | Kansas |
| United States | Univ of Massachusetts Med Ctr | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pharmacia and Upjohn |
United States, Puerto Rico,
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
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