Not Signed In -
Zidovudine Capsule |
Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule |
Clinical Trial: A Comparison of Zidovudine (AZT) Used Alone or in Combination with Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
This study is no longer recruiting patients.
|
Purpose
Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the occurrence of AIDS-related conditions in HIV-infected patients. Secondary: To compare the frequency and severity of adverse experiences in the three regimens. To compare the mortality rates in the three regimens. To compare the effects of antiretroviral regimens on CD4+ cell levels. Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine | Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Official Title: A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Expected Total Enrollment: 1200
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone.
Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. Average follow-up is 2 years.
Eligibility
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Required:
- Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma).
- CD4+ cell count = or < 200/mm3 or = or < 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection.
- Current PCP prophylaxis.
Exclusion Criteria
Co-existing Condition: Patients with the following symptoms and conditions are excluded:
- Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse.
- Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy.
- Stage 2 or worse (moderate) AIDS Dementia Complex.
- Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy.
Concurrent Medication: Excluded:
- Acute therapy for active AIDS-defining opportunistic infection.
- Systemic chemotherapy for malignancy.
- Antiretroviral therapy other than that provided by this study.
Patients with the following prior conditions are excluded:
- History of pancreatitis or peripheral neuropathy of grade 2 or worse.
- History of intolerance to the study drugs at entry doses and/or frequencies.
- History of phenylketonuria.
Location Information
California
Community Consortium of San Francisco, San Francisco, California, 94110, United States
Colorado
Denver CPCRA / Denver Public Hlth, Denver, Colorado, 802044507, United States
Connecticut
Hill Health Corp, New Haven, Connecticut, 06519, United States
Delaware
Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware, 19899, United States
District of Columbia
Veterans Administration Med Ctr / Regional AIDS Program, Washington, District of Columbia, 20422, United States
Georgia
AIDS Research Consortium of Atlanta, Atlanta, Georgia, 30308, United States
Illinois
AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States
Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States
Michigan
Henry Ford Hosp, Detroit, Michigan, 48202, United States
Comprehensive AIDS Alliance of Detroit, Detroit, Michigan, 48201, United States
New Jersey
North Jersey Community Research Initiative, Newark, New Jersey, 071032842, United States
New York
Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York, 10037, United States
Clinical Directors Network of Region II, New York, New York, 10011, United States
Addiction Research and Treatment Corp, Brooklyn, New York, 11201, United States
Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon, 972109951, United States
Virginia
Richmond AIDS Consortium, Richmond, Virginia, 23298, United States
L Saravolatz, Study Chair
D Winslow, Study Chair
More Information
Click here for more information about Zidovudine
Click here for more information about Zalcitabine
Click here for more information about Didanosine
Publications
[No authors listed] New trials reach same conclusion: two drugs are better than AZT alone. Aids Alert. 1995 Nov;10(11):133-6. No abstract available.
Saravolatz LD, Collins G, Hodges D, Winslow D, Pettinelli C. A randomized, comparative trial of ZDV versus ZDV plus ddI versus ZDV plus ddC in persons with CD4 cell counts of less than 200/mm3. Int Conf AIDS. 1996 Jul 7-12;11(1):21 (abstract no MoB291)
[No authors listed] Ethnicity and treatment. PI Perspect. 1997 Jul;(No 22):15-6. No abstract available.
Besch CL, Morse E, Simon P, Hodges J, Franchino B. Preliminary results of a compliance study within CPCRA 007 combination nucleoside study (NuCombo). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:111 (abstract no 254)
Mayers D, Saravolatz L, Winslow D, Jagodzinski L, Collins G, Hodges D, Pettinelli C, Weislow O, Stein D. Viral burden measurements in CPCRA 007. Int Conf AIDS. 1996 Jul 7-12;11(Program Supplement):16 (abstract no ThB911)
Kumi J, Collins G, Saravolatz L. Does ethnicity influence the efficacy and toxicity of combination versus monotherapy with nucleosides in AIDS patients? Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:166 (abstract no 547)
James JS. AZT, ddI, and ddC combinations at FDA advisory hearing. Food and Drug Administration. AIDS Treat News. 1996 Apr 5;(no 244):6. No abstract available.
[No authors listed] Researchers are rethinking role of AZT in drug therapy. AIDS Policy Law. 1995 Oct 6;10(18):11. No abstract available.
Saravolatz LD, Winslow DL, Collins G, Hodges JS, Pettinelli C, Stein DS, Markowitz N, Reves R, Loveless MO, Crane L, Thompson M, Abrams D. Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 1996 Oct 10;335(15):1099-106.
Randall P. CPCRA 007: preliminary results of combination antiretroviral study. NIAID AIDS Agenda. 1996 Mar;:2. No abstract available.
Record last reviewed: August 2004
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00001022
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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