Expired Study
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Chicago, Illinois 60657


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

CPCRA 007


NCT ID:

NCT00001022


Secondary ID:

11559


Study Acronym:


Brief Title:

A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients


Official Title:

A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients


Overall Status:

Completed


Study Phase:

Phase 3


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:

1200


Enrollment Type:


Overall Contact Information

Official Name:L Saravolatz
Study Chair

Study Dates

Completion Date:December 1995
Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 30, 2012
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Zalcitabine
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:[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.
PMID:11362921
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation:[No authors listed] Ethnicity and treatment. PI Perspect. 1997 Jul;(No 22):15-6. No abstract available.
PMID:11364573
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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)
Reference Type:Reference
Citation: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.
PMID:11363307
Reference Type:Reference
Citation:[No authors listed] Researchers are rethinking role of AZT in drug therapy. AIDS Policy Law. 1995 Oct 6;10(18):11. No abstract available.
PMID:11362821
Reference Type:Reference
Citation: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.
PMID:8813040
Reference Type:Reference
Citation:Randall P. CPCRA 007: preliminary results of combination antiretroviral study. NIAID AIDS Agenda. 1996 Mar;:2. No abstract available.
PMID:11363796
Reference Type:Results Reference
Citation:Randall P. CPCRA 007: preliminary results of combination antiretroviral study. NIAID AIDS Agenda. 1996 Mar;:2. No abstract available.
PMID:11363796

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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