Completed
A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
1200
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparison of Zidovudine (AZT) Used Alone or in Combination With Didanosine (ddI) or Dideoxycytidine (ddC) in HIV-Infected Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 16 locations
1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
Status Unknown
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 80204
Status Unknown
3
Hill Health Corp
New Haven, Connecticut, United States, 06519
Status Unknown
4
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
Status Unknown
5
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422
Status Unknown
6
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Status Unknown
7
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
8
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
9
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States, 48201
Status Unknown
10
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
11
North Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
Status Unknown
12
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Status Unknown
13
Clinical Directors Network of Region II
New York, New York, United States, 10011
Status Unknown
14
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
15
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
Status Unknown
16
Richmond AIDS Consortium
Richmond, Virginia, United States, 23298
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Ethnicity and treatment.
https://pubmed.ncbi.nlm.nih.gov/11364573AZT, ddI, and ddC combinations at FDA advisory hearing. Food and Drug Administration.
J S James
https://pubmed.ncbi.nlm.nih.gov/11363307Researchers are rethinking role of AZT in drug therapy.
https://pubmed.ncbi.nlm.nih.gov/11362821Zidovudine 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.
L D Saravolatz, D L Winslow, G Collins...
https://pubmed.ncbi.nlm.nih.gov/8813040CPCRA 007: preliminary results of combination antiretroviral study.
P Randall
https://pubmed.ncbi.nlm.nih.gov/11363796Exploring causal mechanisms and quantifying direct and indirect effects using a joint modeling approach for recurrent and terminal events.
Fang Niu, Cheng Zheng, Lei Liu
https://pubmed.ncbi.nlm.nih.gov/37461207