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
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ClinicalTrials.gov Identifier: NCT00000803 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 4, 2012
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Delavirdine mesylate Drug: Zidovudine Drug: Didanosine | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 471 participants |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Actual Study Completion Date : | March 1997 |


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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000803

Study Chair: | Friedland G | ||
Study Chair: | Fischl MA | ||
Study Chair: | Pollard R |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000803 History of Changes |
Other Study ID Numbers: |
ACTG 261 11238 ( Registry Identifier: DAIDS-ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 4, 2012 |
Last Verified: | April 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Didanosine |
Delavirdine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |