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A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy

13 Years
Not Enrolling
HIV Infections

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Trial Information

A Prospective, Randomized, Open-Label, Comparative Trial of Dideoxyinosine (ddI) Versus Dideoxycytidine (ddC) in HIV-Infected Patients Who Are Intolerant of or Who Have Failed Zidovudine (AZT) Therapy

Alternative and less toxic treatments need to be investigated for the treatment of HIV
infection. Studies have shown that the dideoxynucleosides ddI and ddC may be effective
antiretroviral agents in the treatment of HIV-infected individuals. However, ddI and ddC
have yet to be compared on the basis of patient survival, drug tolerance, immunologic and
virologic effectiveness, and the incidence of opportunistic infection or opportunistic
malignancy. Results of this study will yield information regarding the relative therapeutic
benefits and toxicities of each drug while providing alternative treatment to patients who
are unable to tolerate or have had progression of disease while on AZT.

After baseline screening, patients are randomized to one of two treatment arms (ddI or ddC).
Subjects are evaluated biweekly for the first 4 weeks of study, at 2 months, and every other
month thereafter. Three dose levels of ddI (based on patient's weight at study entry) are
compared with two dose levels of ddC (also based on patient weight). Patients who reach a
new progression-of-disease primary endpoint after at least 12 weeks of treatment or a drug
intolerance endpoint have the option of switching over to the alternate study drug; however,
participants are encouraged to remain on their original drug assignment whenever possible.
For any switchover, patients must be off the originally assigned drug for at least 72 hours
before switching. Only one switchover is allowed.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- Acyclovir (if patient is also receiving ddC, clinical monitoring should be more

- Analgesics, antiemetics, antidiarrheal agents, or other necessary treatment for
symptomatic therapy.

- Interferons for maintenance therapy of Kaposi's sarcoma.



- Prophylaxis against Pneumocystis carinii pneumonia (PCP) if their absolute CD4+
lymphocyte count is < 200 cells/mm3 at study entry. PCP prophylaxis for patient with
CD4+ counts between 200 and 300 cells/mm3 is at discretion of patient's primary

- NOTE: There is potential interaction of ddI and dapsone.

Concurrent Treatment:


- Transfusion, erythropoietin.

Patients must have the following:

- Zidovudine (AZT) failure after having received a cumulative duration of at least 6

- AZT intolerance - rechallenge is not required for patients exhibiting = or > grade
III cutaneous symptoms.

- Diagnosis of AIDS or CD4+ = or < 300 cells/mm3 OR AIDS-defining illness other than
Kaposi's sarcoma.

- Willingness and ability to comply with protocol.

- Informed consent must be obtained for all study participants in accordance with state
law, local IRB requirements, and 45 CFR Part 46. AMENDED 11/19/90 to include assent
by minors if they are physically able, in addition to consent by parents.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Any disorders for which the study drugs are contraindicated (didanosine (ddI)) is
contraindicated in renal impairment, heart disease, receiving renal dialysis.

- Active opportunistic infection.

Concurrent Medication:


- Other antiretroviral agents.

- Use of drugs associated with peripheral neuropathy or use of agents that may cause
pancreatitis including intravenous pentamidine and alcohol should be restricted or

Concurrent Treatment:


- Other concurrent antiretroviral clinical trials.

Patients with the following are excluded:

- History of pancreatitis, peripheral neuropathy, uncontrolled seizures, renal
impairment, heart disease, stage 2 or higher ADC.

- Any other disorders for which the study drugs are contraindicated, i.e., ddI is
contraindicated in renal impairment, patients receiving renal dialysis, and heart

- Receiving acute therapy for active AIDS defining opportunistic infection on

Prior Medication:


- Didanosine (ddI).

- Dideoxycytidine (ddC) .

Excessive alcohol use that, in investigator's opinion, puts patient at risk of developing
pancreatic disease.

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Kaplan C

Investigator Role:

Study Chair



Study ID:




Start Date:

Completion Date:

September 1992

Related Keywords:

  • HIV Infections
  • Zalcitabine
  • Didanosine
  • Drug Evaluation
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



Community Consortium of San Francisco San Francisco, California  94110
Denver CPCRA / Denver Public Hlth Denver, Colorado  802044507
Veterans Administration Med Ctr / Regional AIDS Program Washington, District of Columbia  20422
AIDS Research Consortium of Atlanta Atlanta, Georgia  30308
AIDS Research Alliance - Chicago Chicago, Illinois  60657
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med New Orleans, Louisiana  70112
Henry Ford Hosp Detroit, Michigan  48202
Comprehensive AIDS Alliance of Detroit Detroit, Michigan  48201
North Jersey Community Research Initiative Newark, New Jersey  071032842
Harlem AIDS Treatment Group / Harlem Hosp Ctr New York, New York  10037
Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland, Oregon  972109951
Richmond AIDS Consortium Richmond, Virginia  23298
Hill Health Corp New Haven, Connecticut  06519
Wilmington Hosp / Med Ctr of Delaware Wilmington, Delaware  19899
Bronx Lebanon Hosp Ctr Bronx, New York  10456
Clinical Directors Network of Region II New York, New York  10011