Phase I/II trial of thymosin fraction 5 and thymosin alpha one in HTLV-III seropositive subjects.
Schulof. R S RS; Simon. G L GL; Sztein. M B MB; Parenti. D M DM; DiGioia. R A RA; Courtless. J W JW; Orenstein. J M JM; Kessler. C M CM; Kind. P D PD; Schlesselman. S S
Key Findings
- 60 mg TF5 daily improved T‑cell proliferative response (MLR) in 6 HTLV‑III‑positive subjects
- Transient normalization of IL‑2 production was seen with 60 mg TF5
- No major toxicity observed; three participants stopped TF5 due to severe skin reactions
- No impact on CD4 counts, NK activity, viral antibody levels, or overall AIDS progression except that those with improved MLR did not develop AIDS
Practical Outcomes
- For biohackers, the only actionable hint is that a 60 mg daily sub‑Q dose of TF5 may modestly boost certain immune functions in severely immunocompromised people, but it’s untested in healthy individuals and carries a risk of skin irritation. It’s not ready as a general longevity or performance protocol without further research.
Summary
In a small early‑stage trial, daily injections of a thymosin mixture (TF5) at 60 mg helped restore a specific immune test (MLR) in a few people with advanced HIV‑like infection, without serious side effects except occasional skin irritation. The single‑dose thymosin‑alpha‑1 didn’t show benefits, and overall the treatment didn’t change key virus‑related markers or prevent disease in most participants.
Abstract
Forty-two male homosexuals and/or hemophiliacs with depressed helper/suppressor T-cell ratios were treated with one of three different doses of thymosin fraction 5 (TF5, 30, 60, and 120 mg), or a single dose of thymosin Alpha One (TA1, 600 micrograms), by daily subcutaneous (SQ) administration for 10 weeks, followed twice weekly for 4 weeks. No major toxicity was noted for any of the preparations tested, although three subjects treated with TF5 had to discontinue therapy because of severe local skin reactions. Of the doses and preparations tested, only 60 mg TF5 was capable of significantly improving (p less than 0.02) mean T-cell lymphoproliferative responses to alloantigens (MLR) for six HTLV-III seropositive subjects who were abnormal prior to therapy. Peripheral blood lymphocytes from subjects treated with 60 mg TF5 also exhibited a transient restoration of mean mitogen-induced interleukin-2 (IL-2) production to normal. No effects were observed with any of the four treatment regimens on absolute helper T-cell numbers, NK activity, antibody titers to HTLV-III, or in the expression of a variety of surrogate markers for acquired immunodeficiency syndrome (AIDS). Four of the six seropositive subjects treated with 60 mg TF5 exhibited a return to depressed baseline MLR, after switching to twice weekly injections. With a median follow-up time of 20 months, six cases of AIDS developed. However, none of the five subjects whose MLR improved following treatment progressed to AIDS. We recommend daily subcutaneous (SQ) administration of 60 mg (40 mg/m2) TF5 for use in combined modality trials, along with drugs capable of suppressing replication of HTLV-III.
Study Information
pubmed
1986