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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


N/A
13 Years
N/A
Not Enrolling
Both
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:

Allowed:

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

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

- Interferons for maintenance therapy of Kaposi's sarcoma.

- GM-CSF.

Required:

- 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
physician.

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

Concurrent Treatment:

Allowed:

- Transfusion, erythropoietin.

Patients must have the following:

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

- 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:

Excluded:

- 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
avoided.

Concurrent Treatment:

Excluded:

- 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
disease.

- Receiving acute therapy for active AIDS defining opportunistic infection on
enrollment.

Prior Medication:

Excluded:

- Didanosine (ddI).

- Dideoxycytidine (ddC) .

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

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Kaplan C

Investigator Role:

Study Chair

Authority:

Unspecified

Study ID:

CPCRA 002

NCT ID:

NCT00000969

Start Date:

Completion Date:

September 1992

Related Keywords:

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

Name

Location

Community Consortium of San FranciscoSan Francisco, California  94110
Denver CPCRA / Denver Public HlthDenver, Colorado  802044507
Veterans Administration Med Ctr / Regional AIDS ProgramWashington, District of Columbia  20422
AIDS Research Consortium of AtlantaAtlanta, Georgia  30308
AIDS Research Alliance - ChicagoChicago, Illinois  60657
Louisiana Comm AIDS Rsch Prog / Tulane Univ MedNew Orleans, Louisiana  70112
Henry Ford HospDetroit, Michigan  48202
Comprehensive AIDS Alliance of DetroitDetroit, Michigan  48201
North Jersey Community Research InitiativeNewark, New Jersey  071032842
Harlem AIDS Treatment Group / Harlem Hosp CtrNew York, New York  10037
Portland Veterans Adm Med Ctr / Rsch & Education GrpPortland, Oregon  972109951
Richmond AIDS ConsortiumRichmond, Virginia  23298
Hill Health CorpNew Haven, Connecticut  06519
Wilmington Hosp / Med Ctr of DelawareWilmington, Delaware  19899
Bronx Lebanon Hosp CtrBronx, New York  10456
Clinical Directors Network of Region IINew York, New York  10011