Comparison of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Saquinavir (Drug); Zidovudine (Drug); Zalcitabine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Collier AC, Study Chair
Corey L, Study Chair
Summary
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir
mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC)
vs. Ro 31-8959 plus AZT plus ddC.
SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of
the three regimens.
Clinical Details
Official title: Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Study design: Treatment
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Prior Medication: Required:
- At least 4 months total of AZT at some point in the past, alone or in combination with
other antiretroviral therapy.
Patients must have:
- HIV seropositivity.
- Diagnosis of AIDS, ARC, PGL, or asymptomatic infection.
- CD4 count > 50 to <= 300 cells/mm3.
- Life expectancy of at least 6 months.
- Prior AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Acute serious opportunistic infections requiring immediate treatment, including (but
not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral
toxoplasmosis, and Pneumocystis carinii pneumonia.
- Known intolerance to Ro 31-8959, AZT, or ddC.
- Symptoms suggestive of pancreatitis.
- Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness,
tingling, burning or pain of the extremities or any related symptoms that are
accompanied by an objective finding.
- Visceral Kaposi's sarcoma.
- Lymphoma that will require therapy within the next 6 months.
- Transfusion dependence.
Concurrent Medication:
Excluded:
- Investigational or antineoplastic agents.
Concurrent Treatment:
Excluded:
- Radiotherapy (other than local skin radiotherapy).
- Transfusions.
Prior Medication:
Excluded:
- Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days
prior to study entry.
- Prior treatment with an HIV proteinase inhibitor.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Stanford Univ Med Ctr, Stanford, California 943055107, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Northwestern Univ Med School, Chicago, Illinois 60611, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Univ of Rochester Med Ctr, Rochester, New York 14642, United States
Ohio State Univ Hosp, Columbus, Ohio 432101228, United States
Girard Med Ctr, Philadelphia, Pennsylvania 191046073, United States
Univ TX Galveston Med Branch, Galveston, Texas 775550882, United States
Univ of Washington, Seattle, Washington 98122, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Zalcitabine Click here for more information about Saquinavir
Related publications: Schapiro JM, Lawrence J, Speck R, Winters MA, Efron B, Coombs RW, Collier AC, Merigan TC. Resistance mutations to zidovudine and saquinavir in patients receiving zidovudine plus saquinavir or zidovudine and zalcitabine plus saquinavir in AIDS clinical trials group 229. J Infect Dis. 1999 Jan;179(1):249-53. Brambilla D, Coombs R, Bremer JW, Reichelderfer PS, Kalish L, Shapiro DE. The contributions of assay variation and biological variation to the variability of HIV RNA measurements in serially collected clinical specimens. Int Conf AIDS. 1998;12:805 (abstract no 42163) Collier AC, Coombs RW, Schoenfeld DA, Bassett R, Baruch A, Corey L. Combination therapy with zidovudine, didanosine and saquinavir. Antiviral Res. 1996 Jan;29(1):99. Collier AC, Coombs RW, Timpone J, Schoenfeld DA, Bassett R, Baruch A, Corey L. Comparative study of Ro 31-8959 and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. Ro 31-8959, ZDV, and ddC. The ACTG 229 Protocol Team. Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no 058B) Noble S, Faulds D. Saquinavir. A review of its pharmacology and clinical potential in the management of HIV infection. Drugs. 1996 Jul;52(1):93-112. Review. Vanhove GF, Gries JM, Verotta D, Sheiner LB, Coombs R, Collier AC, Blaschke TF. Exposure-response relationships for saquinavir, zidovudine, and zalcitabine in combination therapy. Antimicrob Agents Chemother. 1997 Nov;41(11):2433-8. Collier AC, Coombs RW, Schoenfeld DA, Bassett RL, Timpone J, Baruch A, Jones M, Facey K, Whitacre C, McAuliffe VJ, Friedman HM, Merigan TC, Reichman RC, Hooper C, Corey L. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group. N Engl J Med. 1996 Apr 18;334(16):1011-7. Fischl MA, Stanley K, Collier AC, Arduino JM, Stein DS, Feinberg JE, Allan JD, Goldsmith JC, Powderly WG. Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. The NIAID AIDS Clinical Trials Group. Ann Intern Med. 1995 Jan 1;122(1):24-32. Schapiro JM, Lawrence J, Speck R, Winters MA, Coombs R, Collier AC, Efron B, Merigan TC. HIV RNA and resistance mutations to saquinavir and zidovudine in patients receiving dual versus triple combination therapy. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:154 (abstract no 401)
Last updated: June 23, 2005
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