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Gay Men's Health Crisis
Peptide T Available in New York
Anna Blume
November 15, 1991
GMHC Treatment Issues 1991 Nov 15; 5(8): 9

Peptide T was invented as a potential AIDS therapy in 1986 by a group of scientists, including Dr. Candace Pert at the NIMH. The drug is a string of eight amino acids configured to prevent HIV from attaching to and thus infecting cells. Cells that have already been infected by HIV, prior to therapy with Peptide T, will remain infected until the cell dies. The body, however, less vulnerable to HIV, should have a dramatically enhanced ability to ward off the effects of the virus. In addition to this, Peptide T is a neuronal stimulant which is potentially therapeutic for people with HIV/AIDS. Several phase I clinical trials suggest that Peptide T stabilizes T4-cell counts and improves HIV-related diarrhea, dermatitis, and neuro-cognitive disorders, such as memory or concentration loss, fatigue, and depression.

UPDATE FROM FLORENCE Results from a federally-funded, double-blind, placebo- controlled trial of Peptide T were reported at the international conference in Florence.[1] Dr. Peter Bridge and others studied intranasal doses of drug at 1.2 mg/day, 6 mg/day, and 30 mg/day of Peptide T in 32 patients with AIDS. Trial patients did not take any antiviral drug, but continued pentamidine to prevent PCP. Evaluations of improvement were based on neuropsychologic tests. No toxicity was observed, and the greatest improvement in neuropsychologic function and symptom report was seen in patients taking the lowest dose of intranasal drug; that is, 1.2 mg/day.

Another study from Canada found that injected Peptide T is an effective, non-toxic, pain reliever for HIV-related peripheral neuropathy. Dr. MacFadden, and others, studied the effects of drug in 27 PWA's, nine of whom had peripheral neuropathies.[2] Injections of Peptide T were self-administered at 10 mg/day, and two patients were tapered to 2.5 mg/day in order to determine minimal effective dose. All patients experienced either complete or subjectively significant resolution of lower limb pain, with effects noticed as early as two days after treatment began. Pain recurred gradually within one week of stopping the drug, and began to resolve with reinstitution of treatment. Two patients with sensory loss or numbness did not have improvement from treatment. In this study, no change in immune function could be attributed to Peptide T.

Finally news from Florence evidenced that Peptide T given intravenously, helps nerve cells survive, according to results of 15 AIDS and ARC patients receiving the drug.[3] AVAILABILITY OF DRUG Peptide T is available through two clinical trials: one in Los Angeles for intranasal use, and one in Connecticut for people on methadone and AZT. Additionally, the drug can be bought through buyer's clubs. At the L.A. Buyer's club, the cost of Peptide T at 50 ml is $200.00, a supply that lasts about 40 days at 6 mg/day. (Prices may fluctuate). For more information call (213) 748-1143. The PWA Health Group in New York has also recently received the drug. The cost is $95.00 per 125 mg, a supply which lasts about 21.8 days. For more information call (212) 532-0820.

DOSING AND ADMINISTRATION Peptide T can be administered intravenously (IV -- into the vein), intramuscularly (IM -- into a muscle), or intranasally. IV administration is tricky, requires a block of time for infusion, and must be done under medical supervision. The absorption rate and appropriate dose of IM administration are not yet confirmed. Intranasal administration is the least complicated, although it requires a dose five times as high to achieve the same concentration as IV administration.

Intranasal Peptide T contains benzyl alcohol as a preservative and should not be used for IV or IM injection. In current clinical trials, dosing for intranasal application is 6 mg/day, administered with a pump-like apparatus. Two squirts (1 mg) per nostril, three times per day for a total of 12 squirts/day is necessary to achieve a 6 mg daily dose.

LICENSING AND EXPANDED ACCESS In June 1991 Peptide T was licensed to two companies for further development. Integra Institute and Reed MacFadden, both small companies, hope to conduct phase II trials in New York, Boston, Baltimore, Minneapolis, Seattle, and Portland within three months of receiving their license. Reed MacFadden is planning two trials at this time. One study is for people with advanced AIDS who have failed other therapies for general HIV infection, and the second is planned as a larger trial for people with 150 T cells or less, with symptomatic infection. General symptomology and especially neuropsychology will be monitored.

In November, 1991, a conference on Peptide T at the National Institute of Child Health and Human Development (NICHD) will be held. At this conference, researchers will present papers about testing Peptide T in children with HIV. Due to the low toxicity of the compound, many parents hope that the conference will lead to phase I Peptide T trials in infants and children. It is hoped that such trials will be conducted through the pediatric ACTG Committee.

In Spring, 1991, the Peptide T ATAC (AIDS Treatment Activist Committee) began to demand that the NIMH establish an Expanded Access program to make Peptide T available to all HIV-positive individuals with neuropathy or severe neuropsychological impairment and to persons with HIV/AIDS who have failed or declined treatment with AZT. Integra and Reed MacFadden are currently committing their resources to the phase II trials and have expressed a commitment to design these trials to include an open label access to Peptide T at the end of the study. This would ensure access to all in the trial, even after it is completed. However, there are no immediate plans for a formal expanded access program, which means that there may only be access for the 60 people entered in phase II trials.

Persons with severe cases are encouraged to plead for an Individual Treatment IND by calling Integra at (301) 294-0343; Reed MacFadden at (416) 941-9739 / (301) 653-3990, or FDA officer Paul Richman at (301) 295-8419. There is no guarantee that such an IND will be granted, but the effort may convince officials that people with HIV/AIDS should have access to potentially useful compound, as promising and non-toxic as Peptide T.

REFERENCES 1. VII Internat Conf on AIDS, Abstract #TH.B. 90, Florence, June, 1991.

2. VII Internat Conf on AIDS, Abstract #W.B. 2173, Florence, June, 1991.

3. VII Internat Conf on AIDS, Abstract #M.B. 2049, Florence, June, 1991.

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