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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT00001022
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 1200
Expected to finish: 1995-12-01
Last updated by the study team: 2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Community Consortium of San Francisco — San Francisco, California, United States
Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
Hill Health Corp — New Haven, Connecticut, United States
Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program — Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
AIDS Research Alliance - Chicago — Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
Henry Ford Hosp — Detroit, Michigan, United States
North Jersey Community Research Initiative — Newark, New Jersey, United States
Addiction Research and Treatment Corp — Brooklyn, New York, United States
Clinical Directors Network of Region II — New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.