AIDS TREATMENT NEWS No. 055 - April 22, 1988
John S. James

This "phase I" (dosage and toxicity) study conducted at San Francisco General Hospital found that patients were able to tolerate all six dosage levels (900 mg per day, 1800, 2700, 3600, 4500, and 5400) for the two-month trial. However, four of the 30 patients were dropped from the study, and six others had their doses reduced, due to reactions which may have been side effects of the drug (see "Dextran Sulfate: Monitoring and Safety", below).

This ongoing study did not find evidence of efficacy in patient data analyzed from the first three doses. T-cells showed only an insignificant rise. Only one of several patients who were P24 antigen positive (indicating viral activity) at the start of the trial went negative; and one of several who started negative became positive. This lack of improvement in T4 numbers and viral antigen level does not necessarily mean that the drug does not work, because:

* This study was not designed for efficacy. And only 15 patients have been tested so far.

* Only the lower three of the six doses have been analyzed, as the eight weeks of blood work has not been completed for the other patients. The blood work for these patients on the higher doses is being batched for a single run, to be done soon.

* Two months may not have been long enough to show clear changes on the blood tests.

* We do know that patients felt better with the drug. However there was not enough time to register clinical improvement as studies usually measure it, by reduced numbers of opportunistic infections or other incidents.

* These patients used dextran sulfate alone, and the drug may need to be combined with other treatments to be effective.

* The information has not been formally analyzed for this early report. For example, we know that P24 antigen went negative for only one patient, but we do not know if it decreased for the others.

Dr. Abrams has already written a protocol for "phase II", a study designed to test for efficacy. It will select only patients who are P24 antigen positive to start, use dose ranges but no placebo, and follow patients long enough to see if improvements occur.

The phase II study, like the phase I, will test dextran sulfate alone. But Dr. Abrams has also written another protocol for a trial of dextran sulfate combined with AZT. Theory as well as laboratory evidence suggest that this combination may be more effective than either drug alone. Combined toxicities are unknown at this time.

Private physicians monitoring patients using dextran sulfate (not part of Abrams' study) have reported encouraging results. Usually these patients are combining dextran sulfate with low- dose AZT (generally half dose or less), high dose acyclovir, and often an AL 721 substitute. Usually T-helper cells have shown large increases for those starting with 200 or more; for those with less than 200, T-cell results are inconsistent. Patients also report feeling better, for example having more energy, and have gained weight. But their physicians believe it is too early to tell whether benefits will be sustained beyond the five to six months for which data is available.

Dextran sulfate remains a promising treatment possibility- - especially in combination with other drugs--but at this time nobody can be sure whether or not it will prove helpful. Dextran sulfate stops HIV in the laboratory at concentrations which can be achieved in the bloodstream, suggesting that it might work as a treatment--but not proving that it will.

Dextran Sulfate: Monitoring and Safety

Anyone using dextran sulfate should be monitored by a physician. While the drug has been used in Japan for 20 years and is available there without a prescription, the doses being tried for AIDS and ARC--usually 1800 to 3600 mg per day--are larger then the 900 per day commonly used in Japan.

No one has been harmed by dextran sulfate so far as we know. But there have been minor side effects, and changes in blood tests which might lead to serious problems if not caught early. Until more is known, it makes sense to err on the side of safety.

What we have heard as effects to watch for are:

* High transaminase levels, which could indicate liver toxicity. Most physicians are only seeing these at higher doses, and are not worried by small changes.

* Serious drops in white blood count, or in platelets. We have only heard of this problem in one or two patients. These changes may not have been due to dextran sulfate; but just in case, these values should be monitored.

* Some patients report a bloated feeling, or diarrhea, especially when starting the treatment.

* We have heard one report of a nosebleed. However, the San Francisco General trial has not found any coagulation problems.

* Especially at very large doses, some patients in the San Francisco test reported feeling "speedy".

The Japanese PDR (Physician's Desk Reference) lists other precautions. These are translated in AIDS Treatment News #50.

For more information on dextran sulfate, including availability, call Project Inform, 800-822-7422 (U.S. except California), 800-334-7422 (California only), or 415-558-9051 from anywhere.

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