Expired Study
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Aurora, Colorado


Purpose:

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.


Study summary:

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.


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 is Available At:


Original ID:

ACTG 261


NCT ID:

NCT00000803


Secondary ID:

11238


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

471


Enrollment Type:


Overall Contact Information

Official Name:Friedland G
Study Chair

Study Dates

Completion Date:March 1997
Completion Type:Actual
Verification Date:April 2012
Last Changed Date:April 2, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Delavirdine mesylate
Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Didanosine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Demeter LM, Meehan PM, Morse G, Gerondelis P, Dexter A, Berrios L, Cox S, Freimuth W, Reichman RC. HIV-1 drug susceptibilities and reverse transcriptase mutations in patients receiving combination therapy with didanosine and delavirdine. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Feb 1;14(2):136-44.
PMID:9052722
Reference Type:Reference
Citation:Friedland GH, Pollard R, Griffith B, Hughes M, Morse G, Bassett R, Freimuth W, Demeter L, Connick E, Nevin T, Hirsch M, Fischl M. Efficacy and safety of delavirdine mesylate with zidovudine and didanosine compared with two-drug combinations of these agents in persons with HIV disease with CD4 counts of 100 to 500 cells/mm3 (ACTG 261). ACTG 261 Team. J Acquir Immune Defic Syndr. 1999 Aug 1;21(4):281-92.
PMID:10428106
Reference Type:Reference
Citation:Nokta M, Turk P. Partial restoration of HIV specific neutralizing activity (NA) of HIV infected patients receiving antiretrovial therapy: DDI/delaviridine (DLV), AZT/DLV, DDI/AZT or DDI/AZT/DLV. Int Conf AIDS. 1998;12:516 (abstract no 31108)
Reference Type:Reference
Citation:Freimuth WW, Chuang-Stein CJ, Greenwald CA, Wathen LK, Edge-Padbury BA, Cox SR, Daenzer CL, Wang Y, Carberry PA. Delavirdine (DLV) combined with zidovudine (ZDV) or didanosine (ddI) produces sustained reduction in viral burden and increases in CD4 count in early and advanced HIV-1 infection. Int Conf AIDS. 1996 Jul 7-12;11(1):22 (abstract no MoB295)
Reference Type:Reference
Citation:Griffit B, Morse G, Demeter L, Bassett R, Hughes M, Friedland G. Relationship between delavirdine (DLV) plasma levels, HIV RNA responses and DLV resistance during combination therapy with zidovudine (ZDV), and didanosine (ddI). Int Conf AIDS. 1998;12:52 (abstract no 12206)

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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