Product Information

AZT-d4T Warning:

Preliminary results of ACTG 290 suggest that these two drugs may be antagonistic. ACTG 290 is a phase II study of various antiretroviral drug regimens (d4T/AZT, d4T alone, ddI/AZT and ddI alone) for patients with CD4 counts 300-600 cells/mm3 and prior AZT exposure. Interim cells analysis showed that participants receiving AZT/d4T had a median CD4 decline of 82 cells/mm3 at 36 weeks, significantly worse than the group receiving d4T alone. Consequently, the d4T/AZT arm of ACTG 290 is being discontinued, and "A Note to Physicians" warning against the possible deleterious effects of this combination has been released by the U.S. Public Health Service. Additional analyses being conducted at this time include a review of viral burden results in ACTG 290 and a review of a similar study, ACTG 298. Pending further information, physicians are urged to take these results into account when selecting antiviral regimens.

Update on Nelfinavir (Viracept):

Agouron Pharmaceuticals announced on January 8, 1997 that the access program for Viracept will be expanded. Requirements for inclusion are:

1. CD4 count <100 cells/mm3 at any previous time, plus
2. intolerance or failure with indinavir and/or ritona-vir.

(For further information call 800-621-7111 Monday through Friday from 8:00 a.m. to 6:00 p.m. EST.) Agouron submitted a New Drug Application (NDA) to the FDA for Viracept on December 23, 1996 based on studies of Viracept in combination with d4T and in combination with AZT plus 3TC. This is the first request for FDA approval of a protease in-hibitor for both adults and children.

Patient Assistance Programs for HIV Viral Load Testing:

Roche has announced a patient assistance program consisting of a counseling service for patients, physicians or insurance companies for the Roche HIV RNA PCR assay. The contact number is 888-TEST-PCR. Hours of operation are 9:00 a.m. to 5:00 p.m. Monday through Friday. Chiron has also announced a patient assistance "hotline" for its quantitative bDNA assay that can be reached at 888-HIV-LOAD.

National Hemophilia Foundation Announces that Pharmaceutical Firms have Agreed to Proceed with Settlement:

Four blood product firms (Bayer, Baxter, Armour and Alpha Therapeutics) are alleged to have managed the blood supply negligently in the 1980's resulting in HIV transmission, and have announced that they will offer each eligible claimant a $100,000 settlement. The deadline for the settlement offer was October 15, 1996. About 6,200 or 92% of those who responded indicated they wanted to participate. Alternatives included pursuit of private lawsuits. Judge John F. Grady postponed approval of the settlement pending resolution of contingency issues: adequate notification of the affected population, including patients and families, a sufficient monetary allocation, and protection of pharmaceutical firms against further lawsuits by those who agree. The National Hemophilia Foundation is attempting to make sure that this settlement does not interfere with eligibility for federal aid in cluding Medicaid benefits.

Nitazoxanide Available Through a Compassionate Access Program:

Nitazoxanide has proven partially effective in AIDS patients with crypto-sporidiosis. In an open-label phase I/II trial in 30 patients with daily doses ranging from 500 mg to 2,000 mg, 18% had complete resolution of diarrhea; 18% had a 50% reduction in daily stools, and cryptosporidia cysts were cleared or nearly cleared from stool in 33% [Davis LJ et al: 36th ICAAC, Abstract LM 50, New Orleans, September, 1996]. This drug is now available for open-label compassionate use for patients with the following eligibility criteria:

1. Age 3-65 years;

2. AIDS diagnosis;

3. CD4 count <200 cells/mm3 or documented cryptosporidiosis for at least four weeks;


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4. diagnosis of cryptosporidiosis by stool exam and chronic diarrhea with at least four bowel movements/day for at least two weeks (or over four weeks if the CD4 count exceeds 200 cells/mm3);

5. cryptosporidiosis refractory to other therapies;

6. informed consent.

Nitazoxanide has a spectrum of activity somewhat similar to metronidazole including Trichomonas vaginalis, Entamoeba histolytica, and nearly all anaerobes; in fact, it is more active than metronidazole versus most anaerobic bacteria. It is substantially more active than paromomycin in the kidney cell model of cryptosporidia infection. Participants in the compassionate access program are randomized to receive 1,000 mg/day or 2,000 mg/day with the option of dose increases at four weeks. For further information, contact Unimed at 800-541-3492.

Amphotec is FDA Approved for Invasive Aspergillosis:

Amphotec (amphotericin B cholesteryl sulfate complex) is a lipid-based delivery system for amphotericin B that has been approved by the FDA. It is indicated for invasive aspergillosis when amphotericin B cannot be given due to renal impairment, unacceptable toxicity, or failure. The major advantage of Amphotec is reduced nephrotoxicity; the major disadvantage is high cost. The usual dose of Amphotec is 3-6 mg/kg/day by IV infusion. The most common complications in non-comparative studies with 572 patients were chills in 50% and fever in 33%. In a double-blind comparative trial with amphotericin B, azotemia occurred in 28% of those receiving amphotericin B compared to 20% in those receiving Amphotec. Those wishing further information should call Sequus at 800-323-9049.