AIDS TREATMENT NEWS No. 113 - October 19, 1991
John S. James

* To obtain ddC under this program, patients can qualify by AZT treatment failure, or AZT intolerance, or AZT ineligibility.

* To qualify under AZT treatment failure, patients must have received at least 500 mg/day of AZT for at least six months, and not been off of the drug for more than 30 days during that six-month period. They must have had at least one of the following:

- Three opportunistic infections or cancers in the last six months; or

- Drop of 50 T-helper cells, and a T-helper count of less than 50 on two occasions one month apart; or

- Sustained or increasing p24; or

- Involuntary weight loss of 2-2.5 pounds per week for at least four weeks; or

- Significant neurologic deterioration; or

- Karnofsky score less than or equal to 40 for at least one month, as a result of AIDS.

* To qualify under AZT intolerance, patients must have remained intolerant to AZT although the dose was reduced to 500 mg per day or less. Intolerance is defined as one or more of the following:

- Decrease in hemoglobin by 2 gm/month; or

- ANC less than 750; or

- Severe vomiting or intractable nausea due to AZT; or

- Severe headaches not treatable by analgesics; or

- Acute psychosis; or

- Severe agitation; or

- Declining muscle strength, such as inability to climb stairs, with CPK greater than 1000.

These toxicities must have required discontinuation of AZT, and must resolve to Grade 2 or better within 45 days after discontinuing AZT, and before entry into this ddC protocol.

* To qualify under AZT ineligibility, patients must:

- Be taking necessary treatment with drugs which cannot safely be given with AZT and could be given with ddC (e.g., ganciclovir for life-threatening or sight-threatening CMV infections); or

- Have baseline ANC less than 1000, and no prior use of AZT; or

- Have baseline hemoglobin less than 8.5.

* The protocol also defines ddI intolerance and ineligibility. Originally, patients could receive ddC only if they had failed both AZT and ddI. After protests by activists, who objected to patients being required to fail other than standard therapies, this "ddI loop" was eliminated. ddI intolerance or ineligibility are no longer required for access to ddC, but the information is still being collected, for research purposes.

* The AZT toxicities described above "would be considered met:

- Logical time course following drug administration;

- A known toxicity of the drug;

- Improvement after discontinuation of the drug;

- Recurrence with rechallenge with the drug."

(Note that these criteria do not necessarily require rechallenge, which would be dangerous in some circumstances.)

* Patients must also meet all of the following conditions:

- Hemoglobin at least 8.0 and not transfusion dependent;

- ANC at least 750;

- Platelet count at least 80,000;

- Estimated creatinine clearance greater than 50 ml/minute (a formula is given for making the estimate);

- SGOT and SGPT less then five times upper limit of normal (in some cases, a hepatitis B surface antigen test should be done);

- Both men and women must practice birth control, and women must have a negative serum beta HCG pregnancy test within seven days of entry into the protocol;

- Patients must be at least 12 years old, with consent of parent or guardian for those under 18.

* Exclusion criteria. Patients must not have any of the following:

- A history of peripheral neuropathy due to any cause -- or any finding suggestive of peripheral neuropathy found at baseline neurological exam (An isolated finding of absent Achilles reflex may be allowed.); or

- Cancer other than KS or basal cell carcinoma; or

- Concomitant treatment with any other nucleoside analog (e.g., AZT); or

- Concomitant treatment with excluded medications. ("Excluded medications include other experimental drugs, immune modulators, systemic corticosteroids, drugs with known nephrotoxic or hepatotoxic potential, and drugs likely to cause peripheral neuropathy."); or

- Pregnancy or breast feeding; or

- Being unwilling or deemed unable to sign an informed consent.

* Concomitant medications. Most non-experimental medications are permitted when necessary. But any that could cause peripheral neuropathy should be avoided. And other precautions are recommended or required; for example, ddC must be stopped temporarily if certain drugs need to be administered.

Disclaimer

This article summarizes the eligibility criteria of the ddC expanded-access program; it is not complete. In addition, the criteria will probably change over time. The above summary is for background only.

For detailed information about this ddC expanded-access program, physicians only should call 800/ddC-21HIV (800/332- 2144), Monday through Friday, 9 a.m. to 8 p.m. Eastern Time. For more information about ongoing ddC clinical trials, patients or physicians can call the AIDS Clinical Trials Information Service at 800/TRIALS-A (800/874-2572), or Hoffmann-La Roche at 800/526-6367.

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