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AIDS Trestment News
July 16, 1999

Contents:


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Major Advance in Protecting Newborns: One Nevirapine Dose Cuts Infection in Half

by John S. James


A study in Uganda, sponsored by the U.S. National Institute of Allergy and Infectious Diseases, found that a single oral dose of nevirapine given to an HIV-infected woman in labor, plus one dose to the infant within three days of birth, cut HIV transmission to 13.1%, compared to 25.1% with a similar short course of AZT. Drug cost, based on U.S. wholesale prices, is 200 times less than that of the standard AZT regimen used in developed countries. Treatment begins during labor, so it can be used for women who do not receive prenatal care. In some parts of Africa, up to 30% of pregnant women have HIV, and 25% to 35% of their infants are infected. An estimated 1,800 HIV-infected babies are born every day, and up to 1,000 a day could be saved from infection with the new treatment.

To avoid the need to test pregnant women and identify who is HIV-positive -- a serious problem in some societies, where confidentiality would be difficult or impossible -- pregnant women might be routinely treated in areas of high HIV incidence.

The Uganda study, led by Professor Francis Mmiro from Makerere University and Brooks Jackson from Johns Hopkins University, is continuing to follow the infants for their first 18 months, to confirm the safety of the treatment, and to make sure that the gains are not lost through HIV infection during breast feeding.

Nevirapine, marketed as Viramune® in the U.S., was developed by Boehringer Ingelheim Pharmaceuticals and is approved in the U.S. and other countries for treatment of HIV-infected adults, in combination with other antiretrovirals. It is very active against HIV, but viral resistance develops rapidly if it is used alone as a continuous treatment by someone who is already HIV infected.

The new single-dose nevirapine regimen will be used in the U.S. and elsewhere for pregnant women who do not know they are HIV-positive until they begin labor, when it is too late to take the full standard regimen. Also, an ongoing study in the U.S. and Europe is testing whether adding nevirapine provides additional benefit in preventing HIV transmission, over the AZT and other antiretrovirals which most pregnant women are already taking.



T-20: 5-Drug Combination Trial for Heavily Treated NNRTI-Naive Patients

Now Recruiting:
Central Florida; Atlanta; Los Angeles; New York City; Palm Springs; Pittsburgh; San Diego; San Francisco; St. Louis


T-20 is an antiretroviral that works entirely differently than any approved drug, and seems to have few side effects. It may be important in improving the treatment options available after failure of other antiretroviral combinations.

A trial of T-20 in combination with four approved antiretrovirals is now recruiting in seven U.S. cities. Volunteers must have failed at least one regimen containing a protease inhibitor, and must not have taken an NNRTI -- nevirapine, delavirdine, or efavirenz.

All volunteers will receive the following four drugs: abacavir (ZiagenTM), amprenavir (AgeneraseTM), ritonavir (Norvir®, low dose, 200 mg BID), and efavirenz (SustivaTM). Additionally, the volunteers will be randomly assigned to four groups: no T-20, 50 mg twice daily, 75 mg twice daily, or 100 mg twice daily. Seventeen volunteers will be assigned to each group, for a total of 68 in the trial. (After four weeks, the control group will be able to add compassionate-use T-20 if their viral load has not dropped by at least one log, or gone negative, by that time.)

The T-20 will be self-administered by subcutaneous injection. The infusion pumps used in previous T-20 experiments now appear to be unnecessary for this drug.

This trial will last for a total of one year, including a 16- week treatment period and a 32-week treatment extension.

For more information, call Trimeris, Inc., 919-419-6050, and tell the receptionist that you are calling for information about the T-20-206 trial.

[In the San Francisco area, you can either call Trimeris, or call the sites directly: either Quest Clinical Research (investigator Jay Lalezari, M.D.), coordinator Eileen Glutzer, 415-353-0800; or ViRx, Inc. (investigator Steven Becker, M.D.), recruiter Debbie Hildebrandt, 415-474-4440x226 (if voicemail, either leave message or enter '0' for the operator). For any other site, call the Trimeris number, above.]

Notes:

  1. AIDS Treatment News anticipates that important new information about T-20 will be released at the upcoming ICAAC conference (Inter-Science Conference on Antimicrobial Agents and Chemotherapy), September 26-29 in San Francisco.

  2. The developer of T-20, Trimeris, Inc., is also beginning a trial of a related drug, T-1249, which may be more potent and has a different resistance profile. But the T-1249 trial is open to entirely different patients, with much less antiretroviral treatment experience.

  3. On July 12, 1999 Trimeris announced an agreement with Hoffmann-La Roche "for the full-scale clinical testing and development of Trimeris's two novel anti-HIV fusion inhibitors, T-20 and T-1249."



ICAAC Conference in San Francisco, September 26-29


The annual Interscience Conference on Antimicrobial Agents and Chemotherapy will be held September 26-29 in San Francisco's Moscone Center. This large conference -- about 10,000 people usually attend -- focuses on new antibiotics, and has major sections on HIV and related conditions.

This year's conference is likely to have many notable reports on HIV treatment research -- following the historical pattern that ICAAC is most important for AIDS on odd-numbered years, when the World AIDS Conference does not occur and compete for research presentations.

ICAAC is sponsored by the American Society for Microbiology, 202-737-3600. For general registration, ask for the Meetings Department; for press registration, ask for Jim Sliwa. Additional information is also available at http://www.asmusa.org -- click on "Meetings" at the top of the page.



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Resistance Conference Reports

by John S. James


Each summer there is a closed research conference on HIV resistance. This year's meeting, the 3rd International Workshop on HIV Drug Resistance & Treatment Strategies, June 23-26 near San Diego, was particularly hard to get into, because attendance was limited to 200, and also because there is no international conference this year to provide an alternate venue. This writer did not try to attend the meeting. Fortunately several summaries and reports are available on the Web (see below, at the end of this article).

The most definitive record of the conference is the published abstracts; these are not on the Web but were printed in advance of the meeting as a supplement to the journal Antiviral Therapy. Copies are available for $35 plus postage; for more information, send a request to janes@intmedpress.com. [Note: Antiviral Therapy, published by International Medical Press Ltd., should not be confused with Antiviral Research, published by Elsevier -- another journal which also publishes an annual issue containing abstracts from a (different) conference on antiviral drug development.]

Since the abstracts had to be submitted well in advance, often they do not include the most important information from the meeting, either because it was not ready when the abstracts were written, or because it emerged in discussions at the meeting.

For example, RS-344 is a protease inhibitor developed at the U.S. National Cancer Institute. It is not in the abstracts or many of the summaries, but Jules Levin of the National AIDS Treatment Advocacy Project covered it, as follows:

John Erickson, a well-known researcher at the National Cancer Institute, has been in protease inhibitor research from early years and has been reporting for several years at AIDS conferences that he wanted to develop a protease inhibitor specifically designed to be active against viruses containing primary PI [protease inhibitor] resistance mutations. At the Resistance Workshop he discussed RS-344, a PI designed using structure-based approaches with a novel flexible core to target some of the active-site mutants. Erickson reported that RS-344 showed similar potency to currently available protease inhibitors in both enzymatic and cell culture assays. He showed a table of clinical isolates with high- level phenotypic resistance to multiple protease inhibitors. In every case these clinical isolates had either <4-fold or 4-10 fold resistance to RS-344. These clinical isolates had from 8 to 18 mutational changes. Erickson said he thought RS-344 looked good against these highly resistant viruses.


New Drugs in Early Human Trials

There is much interest in ABT-378 from Abbott, and in tipranavir from Pharmacia & Upjohn, mainly because of their potential usefulness in patients who have failed other protease inhibitors. Tipranavir seems to have a notably different resistance profile than approved protease inhibitors. And ABT-378 seemed to work well in patients who had failed a previous protease-inhibitor regimen -- although some researchers saw this trial as a best-case test for second-line treatment, and want to see data on how well the drug will work in the more difficult treatment situations that many doctors and patients face. For more information, see the conference summaries, and the printed abstracts (Session I, "New Antiretrovirals").

Other drugs which may be particularly important include:

  • DAPD, a nucleoside analog which may be active against virus resistant to the approved drugs of that class;

  • AG1549, an NNRTI which may be active against HIV with the K103N mutation, which causes resistance to efavirenz and other drugs in that class;

  • T-1249, a fusion inhibitor like T-20;

  • And others reported in the summaries and the abstracts.


Resistance Conference Summaries on the Web

ATP Doctor Fax, by the AIDS Treatment Project in UK, http://www.atp.org.uk/dff.html (issue #71).

HIVandHepatitis.com, selected highlights of the conference by Harvey S. Bartnof, M.D., http://www.hivandhepatitis.com/html/confrprt.html

IAPAC (International Association of Physicians in AIDS Care): Brief Summary by Mark Mascolini, http://www.iapac.org/conferences/resistance99mm.html

International Medical Press, http://www.intmedpress.com (click on "Rapid Report").

National AIDS Treatment Advocacy Project, http://www.natap.org, has several reports by Jules Levin.

To Be Continued

This article will be continued in a later issue.



Current HIV Treatment Review on Web


In June, 1999, several hundred front-line HIV doctors met for the 9th Annual Clinical Care Options for HIV Symposium, at Laguna Niguel in Southern California. The instructors have now revised their talks and prepared materials into 14 articles on recent developments in HIV treatment, including antiretroviral strategies, drug resistance, drug interactions, new antiretrovirals, metabolic abnormalities, neurological disorders, opportunistic infections, and treatment of viral hepatitis. Other articles look at pathogenesis, HIV vaccines, prevention, and family planning for persons with HIV.

These summaries by leading experts are published as the Medscape HIV/AIDS 1999 Annual Update; publication was made possible by unrestricted educational grants from DuPont Pharmaceutical Co. and Bristol-Myers Squibb. They are available at http://hiv.medscape.com/update99.



Web-Based Survey: Symptom Management for Persons Living with HIV


Bill Holzemer, Professor of Nursing, University of California, San Francisco, is conducting a web-based survey examining symptom management strategies. The goal of the survey is to learn about self-care strategies used to manage symptoms -- and eventually to share those strategies judged effective. The survey is designed to be completed by persons living with HIV, family caregivers, and professional caregivers. If you are interested in participating, please check out the Web site: http://www.hivsymptoms.com.



African Americans: Conference Dates Set


One-day meetings connected with the 1999 National Conference on African-Americans and AIDS have been set for:

Los Angeles, August 4; New York, September 14; Baltimore, September 22-23; and Atlanta, October 14.

These are "designed for clinicians who care for African-American patients infected with HIV, as well as healthcare media, federal and state government agency representatives, federal and state legislators, AIDS service organization officers, social workers, pharmacists, nurses, peer counselors, church leadership, and corrections healthcare personnel." They are sponsored by the Johns Hopkins University School of Medicine.

"The objectives for each conference are to familiarize participants with:

  • The epidemiology of HIV in the United States;

  • Current guidelines and cutting edge clinical modalities for the management of HIV;

  • Current research encompassing drug abuse and its connection to the HIV epidemic;

  • Social and psychiatric concerns of the HIV-infected patient; and

  • Policy initiatives, trends, and political issues which impact all HIV-infected patients."

For registration and other information, fax a request to the National Conference on African Americans and AIDS 2000, 410-995-0610.



New York Area and Worldwide: Call-In Radio Program on HIV


Well-known treatment activist Jules Levin has started a weekly radio program "Living Well with HIV," on WOR Radio (710 on the AM dial) Sunday 11 p.m. to midnight. Listeners can call in questions to experts on the show. The broadcast can be heard as far as Washington, and is also available worldwide through the Web, www.broadcast.com/radio/Talk/WOR/

The program on July 25 will focus on lipodystrophy. Future broadcasts will include information about hepatitis as well as AIDS.

Levin founded the National AIDS Treatment Advocacy Project five years ago, focusing at that time on protease inhibitors. Today a major focus of NATAP is providing treatment information to different ethnic communities in New York.

For more information, call NATAP at 212-219-0106. Suggestions for topics and speakers are welcome.



Help Wanted: National Treatment Educator and Medical Advocate, Los Angeles


Women Alive is seeking a treatment educator to coordinate a 12-site clinical trial patient support and education program. This person will "Develop and implement a training program for trial site advocates. Act as an advocate for HIV-infected women who are enrolled in the WARP AIDS Clinical Trials to make sure that they understand informed consent, receive appropriate medical care, HIV treatments, and services. Educate positive women about the identified pros and cons of participation in a research project. Promote early intervention and treatment access for women with HIV/AIDS. Serve as a link between all 12 site coordinators, and be responsible for overall coordination."

This position is full time, based in Los Angeles, and pays $32,000 to $37,000 per year depending on qualifications. Mail a cover letter and resume to:

Women Alive National TA Interview Committee 1566 S. Burnside, Mid-City Los Angeles, CA 90019

You may want to ask for a full job description. The deadline for submitting requests for interviews is August 14, 1999.



Charges Dropped in Sex Sting; Protecting Yourself Online

by John S. James


Reporter Bruce Mirken, who covers gay youth at risk but also writes occasionally for AIDS Treatment News, was arrested in July last year when he went to Sacramento to see a fictitious gay teenager he had met online two weeks before. The other party was a Sacramento vice officer who had said he was 14 years old (changed to 13 the day before, to increase the penalty under California law), and Mirken was charged with attempted sex with a minor (see "Writer Needs Help: Legal Defense Fund," AIDS Treatment News #310, January 8, 1999).

Last week -- a year and over $55,000 later -- the only remaining charge was dropped after the prosecution presented its case to the jury. The judge ruled that simply meeting in a park, with no attempted touching and no evidence of preparation for a sexual encounter, did not meet the legal standard for "attempt," which requires an unequivocal act toward committing a crime.

At the time of the arrest, San Francisco police seized Mirken's computer and found pictures and conversations which were used against him -- even though all of this evidence had either been quickly deleted, or automatically saved by the software without any action on Mirken's part and without his knowledge.


Safe Conversation Online

Mirken's lawyer, Bruce Nickerson, an expert in police gay-decoy cases, told us the most important rule is to treat whatever one says online (in chat rooms, instant messages, email, etc.) as if it were open to the world; the sense of anonymity is an illusion.

Police are increasingly posing as young people online; the Sacramento online sting, like many others, has arrested only gay men. Unless clear boundaries can be worked out and publicized, adults will become even more nervous about any relationship with gay youth, adding to the isolation which leads to a suicide rate among gay teens which is three to four times that of other teenagers.

After the charges were dismissed, Mirken told us that "one must be cautious, and especially wary of any conversation at all concerning having sex with a juvenile, a huge focus of law enforcement now, rightly or wrongly, and one that will not change soon.

"There are still gay and lesbian teens who desperately need help and support, and we cannot abandon them."


Computer and Internet Privacy

Anyone who uses a computer (whether online or not) should realize that anything they delete is probably not gone unless special precautions are used; deleted information can usually be recovered from the disks by anyone, with publicly available software. In addition, many temporary copies are made by system software without the user's knowledge, and these too can often be retrieved. Downloaded pictures and text may be saved automatically, without the user ever seeing them or knowing about them, or having any way to prove that they were never seen or used -- potentially a problem if they include anything such as sexually explicit language that could be used to inflame a jury, or any information that is a crime to possess (for example, child pornography in the U.S. and many other countries, or certain political or religious information in some countries). Passwords, credit cards, and all kinds of confidential information are also vulnerable.

Most deleted information can be removed permanently by commercially available programs like "Shredder" (for Windows), "Eraser" (for Macintosh) or "Wipe Info." But users need to be aware of the limitations of each program; for example, some only remove deleted information already in the computer, and others only prevent new deleted information from being added, but do not remove what is already there, unless special procedures are followed. Some will remove the contents of deleted files, but not the names of those files. Some do not clean the dangerous Windows "swap file," described by one expert as an "Aladdin's cave" of deleted treasures.

Many email users -- probably the majority -- never open most of the attachments they receive, because of the danger of computer viruses; instead, these attachments usually accumulate in a folder, and are ignored unless they turn out to be needed. Often they are not removed even if the email which carried them is deleted. Unless someone manually deletes the old attachments occasionally -- which is easy to do if they are sorted by date -- they will remain indefinitely on the computer. Some of the hundreds of solicited, unsolicited, and "spam" files may well contain pornography, hate literature, confidential business information, or other material which could be harmful if the computer is stolen, subpoenaed for a lawsuit, seized by law enforcement, or otherwise gets into unfriendly hands.

When using the Web, images from your previous session(s) will usually remain in a cache (temporary memory), unless you either follow a simple procedure to clear the cache after your session, or set your browser to not use a cache in the first place (which will usually slow down your sessions). Some browsers also save a history file -- a record of the sites you visited -- and it may not be obvious how to remove this information.

Also, some applications such as email and database programs can save deleted information in their own files beyond the reach of security software; for example, some word processors may save a new version of a file as the old version plus the editing changes. (We have received text files as email attachments which included previous versions; in one case, we received a document about software which included "slack space" listing songs about torture. It could just as well have included account numbers and passwords, or other confidential business or personal information, from files which had been saved by the sender but later deleted.) Users need to know how to make sure that what they delete is really gone -- and that what they send to others includes no surprises.

Computer users should also know that email can usually be traced, and that some word processors and other applications add hidden identifying information to every document they produce. And they should know that PGP (Pretty Good Privacy) is becoming a de facto standard for encryption.

A particularly serious mistake, when using a private account from a public terminal, is to forget to log off when you leave -- allowing anyone around to gain access to your account.

For more information, see the Center for Democracy and Technology's top ten tips for online privacy, http://www.cdt.org/privacy/guide/basic/topten.html

We would appreciate references to useful Web sites or other information on personal-computer privacy -- both to inform our readers, and to help us make sure that the confidentiality of our subscribers is fully protected. You can reach this writer at jjames@aidsnews.org.



ISSN # 1052-4207

Copyright 1999 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.




  
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