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AIDS Treatment News
October 20, 1995

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Contents:

  1. Viral Load: New "Strategy" Trial in 15 U.S. Cities
  2. International Conference, Vancouver 1996: Arrangements and Deadlines
  3. San Francisco Area: Testosterone Replacement Study, Injection vs. Patch

Viral Load: New "Strategy" Trial 
in 15 U.S. Cities

by John S. James
A new kind of trial which focuses on treatment strategy instead of testing individual drugs is now recruiting 1,100 volunteers with CD4 (T-helper) counts of 300 or less, in the following cities: Albuquerque, Atlanta, Baltimore, Camden NJ, Chicago, Denver, Detroit (2 sites), New Orleans, New York City, Newark, Philadelphia, Portland OR, Richmond VA, San Francisco, and Washington DC.

The main purpose of this trial is to see if testing for plasma HIV RNA ("viral load") can help doctors make better decisions, leading to provable benefits to patients. To test this, half of the volunteers will be randomly assigned to use viral load in making treatment decisions, and the other half will be assigned not to use viral load. The tests will be free for those assigned to use them.

This trial will not tell patients or physicians which treatments to use; that will be decided in the normal course of medical practice. But viral load results will be available to half the patients and physicians to help in making these decisions, and not available to the other half. The trial is expected to run for two to three years.

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Anyone is eligible to enter this trial if they are at least 13 years old, have HIV, have a CD4 count of no more than 300, and are in reasonably good health and willing to take antiretrovirals if needed. They must be receiving treatment from a physician who is participating in the CPCRA program. This trial imposes no restriction on what drugs the patient may use.

This trial is designed and run by the Community Programs for Clinical Research on AIDS (CPCRA), a program of the U.S. National Institute of Allergy and Infectious Diseases (NIAID); the principal investigator is Melanie Thompson, M.D. of the AIDS Research Consortium of Atlanta. Chiron Corporation will donate at least 10,000 bDNA tests for viral load; and SmithKline Beecham, which does medical laboratory testing, will donate the transportation of the samples, a substantial expense since every sample must be shipped in dry ice by overnight express. (The test which will be used is the same one physicians can order, with a cutoff of 10,000 copies of RNA -- not the newer research-only test with a cutoff of about 500 copies.)

A fraction of patients assigned to NOT use HIV RNA will have samples drawn anyway for an HIV RNA test, but the results will not be reported to them or their physician until the end of the trial. The purpose of these samples is to help in scientific analysis of the results.

Patients who are already using viral load or planning to do so should not enter this study, which is for patients and physicians who have not already decided whether or not to use this test. This trial is named CPCRA 036; its official title is A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared with Initiating or Changing Therapy Based on Current Clinical Practice Alone.

For more information about volunteering, call the AIDS Clinical Trials Information Service, 800/TRIALS-A, for the contact telephone number of the CPCRA site in one of the 15 cities listed above.

Comment

This study will develop important information about how physicians are deciding when to switch antiretroviral therapies -- whether those physicians are using viral load tests or not. Also, if it succeeds in proving that viral load tests can have value, it will help to change everyone's standard of care to make these tests more available, not only for those with money or good insurance, but for all. We do have reservations about being randomized to not use viral load testing to guide therapy.

We believe that everyone with HIV should get at least one baseline viral load test -- partly to have it available for comparison with future values, and especially to help decide on how aggressive to be with therapy. If the viral load is high (certainly anything over 100,000 copies is high, and many would aggressively treat values lower than that), the test should be repeated to make sure it was not a temporary high value (which can result from a minor infection, a flu shot or other shot, or from other causes), or due to laboratory error. If the repeat test is also high, we believe that one should use whatever drug combinations, other treatments, or lifestyle changes may be necessary to lower the viral load and keep it down.

Many experts do not agree with our view. Some suspect that the CD4 count "mirrors" viral load sufficiently closely that viral load does not add enough new information to be significant. Also, while everyone agrees that people with high viral load do worse on the average than those with low viral load, some experts argue it has not yet been definitively proved that lowering the viral load by drug treatment will improve a patient's prognosis. It is even possible that viral load testing could indirectly result in harm, by prompting many changes of therapy, exposing patients o more different drug toxicities than they would otherwise face. Also, relying on viral load tests before we know exactly what they mean may lead researchers to discard drugs too soon.

For example, in some trials of protease inhibitors, viral load greatly declined but then became high again, while CD4 count rises were much longer lasting; no one knows what this means, but it is possible that the drug is providing some benefit even when the viral load test is not showing it. Also, it is not known that viral load in the plasma accurately shows viral activity in all body compartments, for example in the central nervous system; it would be unfortunate to discard a drug that provided a benefit which was not readily seen through this test.

The CPCRA viral load study will produce a unique database to answer questions about how well viral load predicts clinical outcome, how it changes with changes in therapy, and how physicians make decisions about antiretroviral treatment. This information will be reviewed monthly as the study proceeds, and will be made available throughout the study to the participating physicians, and through them to the volunteers -- and perhaps even by a World Wide Web page available to everyone. In addition, this study is saving plasma samples from some volunteers for later studies of the effects of drug resistance. Patients and physicians who are already committed to use viral load should not join this study. But those who would not otherwise use viral load can volunteer without reducing the care they receive. And of course if they change their mind later, they can withdraw from the study at any time.


International Conference, 
Vancouver 1996: 
Arrangements, Deadlines

by John S. James
The XI International Conference on AIDS will take place in Vancouver, British Columbia, July 7-12, 1996. Space is tight and the best time to make arrangements is now -- not only for presenters and organizations, but for anyone attending. Deadlines start as early as February 1.

The International Conference on AIDS now occurs once every two years; it was annual until 1994. The theme of the Vancouver conference is, "One World. One Hope" --with four guiding principles of Excellence, Practicality, Sustainability, and Solidarity.

This meeting will introduce a number of innovations:
  • Program formats. As at previous International Conferences, most of information will be presented as oral abstracts and posters; there are also symposia, daily summaries, and raporteur sessions. The Vancouver conference will also include formal debates, skills-building workshops, and "late breaker" sessions (for new material which could not be submitted by the regular deadline).

  • Health insurance for attenders, including persons with HIV, is included in the regular conference registration fee.

  • Three different "pathways" -- Women and HIV, Development and HIV ("individual and societal impact of HIV/AIDS in developing countries and newly independent states"), and Living with HIV -- will be color-coded in the program book.

  • Blinded review of abstracts. The reviewers who evaluate the abstracts will not know who the authors are.

  • A World Wide Web site now includes the 40-page "Second Announcement and Call for Abstracts" at: http://unixg.ubc.ca:780/~fortin/Marcel.html (Note: The 'M' must be capitalized.) Also, the conference secretariat now has an email address as well as other contact information (below). Some conference abstracts will be released online at the time of the conference -- but unfortunately not before.

Deadlines

February 1 is the deadline for:

  • Receipt of abstracts (except for late-breaker sessions), delivered by mail or courier (not by fax) in Vancouver, by 1700 hours;

  • Early registration ($975 Canadian -- which is about $750 U.S., as of October 20). After the deadline, the price goes up;

  • Full refund for registration cancellation (less $60 fee);

  • Scholarship applications. (The government of Canada has funded 1,000 scholarships; more will be offered if funding can be found.)

May 1 is the deadline for:

  • Standard registration;

  • Registration cancellation with 50% refund;

  • Hotel accommodations. Early registration is strongly advised. Because of limited hotel space, it is possible that some registrants may be housed in Whistler, two to three hours away. Most hotel space is reserved for the conference or for other groups, and persons cannot make hotel reservations through the conference without registering first. There is a student discount, which is basically the same as the regular fee, except that it includes accommodations. Media registration is without charge. It requires a photocopy of official press credentials, or a letter from a media organization verifying one's assignment. Freelance journalists must submit three bylined articles; newsletter writers and editors must submit three issues with bylined articles or credit in the masthead. Media may then request hotel accommodations through the conference (which was not allowed in some prior conferences).

A Community Liaison Committee provides advice regarding community participation and program needs of the community, and it coordinates with groups representing people with AIDS, and with AIDS service organizations, throughout the world.

The U.S. representative on this committee is Eric Sawyer, 212/864-5672; or you can call Andrew Johnson in the Community Liaison office at the Conference (see contact information below). Eric stresses that (for any organization that wants to hold a session or otherwise influence the conference) the time to get involved is now; decisions about the conference program will be made starting in November, as abstracts are submitted.

There will not be enough space for all organizations likely to request a meeting room. Note that satellite symposia -- sponsored both by nonprofit organizations (often called "private volunteer organizations," or "non-government organizations," in different countries), and by companies -- will be scheduled for July 6 and July 7, and for July 12; they can also be scheduled in the evenings on the days of the conference itself, which may be especially suitable for nonprofits.

Check-in for the conference is July 6, 12:00 - 18:00, July 7 08:00 -18:00, and July 8-11 07:00 - 16:00. The conference opening ceremony begins at 16:30 on July 7, and the closing ceremony begins at 18:30 hours on July 11. Note: $30 of the regular registration fee can be directed by the registrant to either a 1996 membership in the International AIDS Society, a donation to the Global Network of People Living with AIDS (GNP+), or a donation to the International Council of AIDS Service Organizations (ICASO). The registration form can also be used to make an additional contribution to the scholarship fund.

For more information on registration, travel and hotel arrangements, submission of abstracts, the scholarship program, etc., and for copies of the forms required, contact the XI International Conference on AIDS, Conference Secretariat, PO Box 48740, 595 Burrard St., Vancouver, BC Canada V7X 1T8. Phone: 800/780-AIDS (Canada or U.S.), 604/878-9995 (worldwide), fax 604/668-3242, email aids96@hivnet.ubc.ca. Or use the World Wide Web address above; but note that the Web site does NOT include the registration, accommodation, and other forms.


San Francisco Area: 
Testosterone Replacement Study, 
Injection vs. Patch

by John S. James
Several dozen clinics and physicians' practices in the San Francisco area are now enrolling volunteers in a study of testosterone replacement for men who have abnormally low testosterone levels. This study will compare testosterone injections every two weeks with replacement by a patch which is worn daily on the scrotum; some volunteers will receive a placebo for the first 12 of the 24 weeks of the trial. (Both treatment options are already approved, and can be prescribed by any physician.)

All study-required treatments and tests in the study will be free, except for an initial test for either free or total testosterone level. Low testosterone in men can cause fatigue, loss of energy, reduced sense of well being, reduced sexual drive, and possibly loss of muscle and lean body mass; this deficiency (whether or not HIV-related) has long been treated by testosterone injections. The patch may be a better replacement option, however, as the testosterone is delivered daily, like natural testosterone, not every two weeks as with the injections. Testosterone replacement should not be used in men with known or suspected prostate or breast cancer.

The new study, called Testosterone Replacement in HIV-Related Hypogonadism, is being run by the Community Consortium, an organization of physicians in San Francisco Bay Area. It will randomly assign people to receive either the injections (intra-muscular testosterone enanthate, 200 mg every two weeks) or the patch (Testoderm(TM) by ALZA, worn on the scrotum, which must be shaved). In each of these two groups, two thirds of the volunteers will receive active drug throughout the 24 weeks of the study; the other 1/3 will receive a placebo for 12 weeks, then switch to active drug.

Everyone will have lean body mass measured by DEXA scans (dual energy x-ray absorptiometry), and by BIA (bioelectrical impedance analysis), performed at the General Clinical Research Center (GCRC) of San Francisco General Hospital. Other measurements include weight, serum testosterone levels, CD4 and CD8 counts, viral load, changes in quality of life questionnaires, and self-reported compliance with the study regimens.

This study is open to men over 17 years old, with either serum or free testosterone level below normal. For men over 40, the PSA (prostate-specific antigen, an indication of possible prostate cancer) must be no greater than 4.0. To avoid biasing the study, volunteers cannot have been hospitalized within the last month; and they must not have had a severe illness resulting in loss of more than 10 percent of body weight within six weeks, nor changed their antiretroviral treatment within 30 days. In order to enter this study, you must be seen for your routine care by a physician at a participating site. You can find out if your clinic or physician is participating by calling the Community Consortium, 415/502-0658.

Note: A separate multi-center trial of the Testoderm patch is now being planned.

Comment

Anyone considering testosterone replacement should know that there is now a new testosterone patch which does not need to be worn on the scrotum, but can be worn on the abdomen, back, thighs, or upper arms. This is the Androderm(TM) Testosterone Transdermal System, which was approved by the FDA on October 2, 1995. It is marketed by SmithKline Beecham, and should be in the pharmacies soon. Its main disadvantage is that it often causes skin irritation at the application site.

Another testosterone replacement system is a jell which has been approved in France for ten years; it is not currently available in the U.S., but will soon by tested here by UNIMED, Inc. The jell is applied to the forearm, and delivers a daily dose of testosterone in about 45 seconds.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!




  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 

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