Oral dextran sulfate (UA001) in the treatment of the acquired immunodeficiency syndrome (AIDS) and AIDS-related complex.
OBJECTIVE
To evaluate the tolerance and safety of oral dextran sulfate (UA001), a potent in-vitro inhibitor of human immunodeficiency virus (HIV) in patients with the acquired immunodeficiency syndrome (AIDS) and AIDS-related complex.


METHODS
Unblinded, dose-escalation 8-week trial.


METHODS
An AIDS outpatient clinic of a university-affiliated municipal hospital.


METHODS
Thirty-four patients with stage III or IV HIV infection were enrolled. Five patients in six different dosage cohorts completed the study. The population was predominantly homosexual men with persistent generalized lymphadenopathy (stage III).


METHODS
Oral dextran sulfate was given three times daily in total daily doses of 900 to 5400 mg for 8 weeks. Patients were monitored for tolerance and toxicity. Immunologic and virologic values were also followed.


RESULTS
Oral dextran sulfate was given without significant side effects. The commonest minor subjective complications were mental hyperexcitability and gastrointestinal complaints. The most frequent laboratory abnormalities were leukopenia and hepatic transaminase elevations. Eleven patients required dose reductions, and therapy was stopped in 4 because of toxicities. The CD4 lymphocyte numbers did not change appreciably. No decline in beta-2 microglobulin levels occurred. The HIV antigen levels were unchanged from baseline. No assay for dextran sulfate plasma levels has yet proven successful.


CONCLUSIONS
Oral dextran sulfate appears to be well tolerated. No evidence of systemic absorption of the parent compound is available. However, in view of the promising in vitro effects and acceptable toxicity, oral dextran sulfate as a potential antiretroviral agent continues to be studied.
Abrams
D I
DI
University of California, San Francisco.
Kuno
S
S
Wong
R
R
Jeffords
K
K
Nash
M
M
Molaghan
J B
JB
Gorter
R
R
Ueno
R
R
D000386:AIDS-Related Complex / Q000188:drug therapy*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D015331:Cohort Studies; D016264:Dextran Sulfate; D003911:Dextrans / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
D003911:Dextrans; D016264:Dextran Sulfate