HIV InfectionsPhase 3NCT00002123
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
A Phase 3 study testing Delavirdine mesylate and Didanosine in people with HIV Infections, run by Pharmacia and Upjohn at 84 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Delavirdine mesylate and Didanosine
- How many people
- Not given
- Where
- 84 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- AZT.
- Patients must have:
- HIV-1 seropositivity.
- CD4 count <= 300 cells/mm3.
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- 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.
Who cannot join
- 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).
Show all 25Show fewer
- 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.
Trial locations and contacts
84 sites in 2 countries.
84 sites in 2 countries
United States83 sites
Albany Med College
Albany, New York, 122083479
Univ of Michigan Hospitals and Health Ctrs
Ann Arbor, Michigan, 481090378
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, 30345
Central Texas Med Foundation
Austin, Texas, 78751
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201
East Bay AIDS Ctr
Berkeley, California, 94705
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942041
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Brigham and Women's Hosp
Boston, Massachusetts, 02115
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118
New England Deaconess Hosp
Boston, Massachusetts, 02215
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Med Ctr of Vermont Hosp
Burlington, Vermont, 05401
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
Med Univ of South Carolina
Charleston, South Carolina, 29425
Carolinas Med Ctr
Charlotte, North Carolina, 28204
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Illinois
Chicago, Illinois, 60612
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, 45267
Dallas Veterans Administration Med Ctr
Dallas, Texas, 75216
Univ Hosp / Univ of Colorado Health Sci Ctr
Denver, Colorado, 80262
Harper Hosp
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Duke Univ Med Ctr
Durham, North Carolina, 27710
California Med Research Group
Fresno, California, 93726
Pennsylvania State Univ / Hershey Med Ctr
Hershey, Pennsylvania, 17033
Park Plaza Hosp
Houston, Texas, 77004
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
Univ TX Health Science Ctr
Houston, Texas, 77030
Indiana Univ Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Univ of Iowa
Iowa City, Iowa, 52242
Univ of Kansas School of Medicine / Univ Hosp
Kansas City, Kansas, 661607354
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, 405360084
Los Angeles County - USC Med Ctr
Los Angeles, California, 900331079
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90059
CARE Ctr / UCLA Med Ctr
Los Angeles, California, 90095
Univ of Wisconsin
Madison, Wisconsin, 53792
Univ of Tennessee
Memphis, Tennessee, 38163
Univ of Miami School of Medicine
Miami, Florida, 33136
Vanderbilt Univ
Nashville, Tennessee, 37212
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Community Research Initiative on AIDS
New York, New York, 10001
Beth Israel Med Ctr
New York, New York, 10003
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
New York Hosp - Cornell Med Ctr
New York, New York, 10021
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130
UCI Med Ctr
Orange, California, 92668
Caremark Inc
Palm Beach Gardens, Florida, 33410
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Pennsylvania / HIV Clinic
Philadelphia, Pennsylvania, 19104
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Oncology and Hematology Association
Philadelphia, Pennsylvania, 19146
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, 15261
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, 04102
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
AIDS Community Research Consortium
Redwood City, California, 94063
Richmond AIDS Consortium
Richmond, Virginia, 23219
Community Health Network
Rochester, New York, 14620
Univ of Rochester Med Ctr
Rochester, New York, 14642
UCD Med Ctr / AIDS and Related Disorders Clinic
Sacramento, California, 95817
St Paul Ramsey Med Ctr / HIV Program Office
Saint Paul, Minnesota, 55101
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
St Lukes Medical Group
San Diego, California, 92101
UCSD / Ctr for Special Immunology
San Diego, California, 92103
ViRx Inc
San Francisco, California, 94103
Saint Francis Mem Hosp
San Francisco, California, 94109
Davies Med Ctr
San Francisco, California, 94114
Univ of Washington
Seattle, Washington, 98104
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
Washington Univ
St Louis, Missouri, 63110
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Shared Med Research Foundation
Tarzana, California, 91356
Harbor - UCLA Med Ctr
Torrance, California, 90509
New York Med College / Westchester County Med Ctr
Valhalla, New York, 10595
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Delavirdine mesylate, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delavirdine mesylateDrug
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmacia and Upjohn
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002123
- Sponsor's protocol ID
- 228A
- Other IDs
- M/3331/0017
- Status last verified
- Nov 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002123
- Acronym / sponsor ID
- 228A
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Pharmacia and UpjohnIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- AZT.
- 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.
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delavirdine mesylate | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundFreimuth 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
84 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delavirdine mesylate and Didanosine in people with HIV Infections, run by Pharmacia and Upjohn at 84 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.