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What's New in Treatment Information?

Excerpts From Hotline Memos of March 2000
from the Information Department of Project Inform

April, 2000

Mouth Sores Study Enrolling

The National Institutes of Health (NIH) has asked us to share vitally important information for people with HIV or AIDS and mouth sores. Mouth sores can lead to serious problems: they can interfere with eating and can lead to poor nutrition and other serious health problems.

Doctors from the National Institutes of Dental and Craniofacial Research and the Clinical Center at NIH are looking for people over 17 years of age to take part in a study of a new treatment for mouth sores related to HIV and AIDS. Those who qualify for the study receive care by some of the nation's leading experts in the field.

The study medication, a thalidomide paste applied directly on the sores, is provided free. Patients can stay on their regular medical treatment for HIV or AIDS while participating in this study. NIH staff will accommodate flexible scheduling needs, as well as assist with transportation. The study takes place at the NIH Clinical Center in Bethesda, Maryland.

Patients or their doctors can contact the Principle Investigator of the study, Dr. Sharon Gordon, for more information:

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Telephone: 1-888-606-0220
Fax: 301-496-1005
E-Mail: jbanks@dir.nidcr.nih.gov
Web: http://clinicalstudies.info.nih.gov


Hypersensitivity Reaction and Abacavir (Ziagen)

Glaxo Wellcome, the developers of abacavir (Ziagen), recently sent a letter to physicians alerting them of new symptoms in people who have hypersensitivity reactions to the drug. Previously the symptoms of the hypersensitivity reaction included fever, rash, nausea, vomiting, diarrhea, abdominal pain and fatigue.

More recently, several deaths have been reported in people with respiratory problems like shortness of breath (dyspnea), cough, or inflammation of the pharynx and who were later recognized with hypersensitivity reaction to abacavir. About 20% of people who initially experienced this hypersensitivity reaction had these respiratory symptoms.

The diagnosis of hypersensitivity reaction should be carefully considered for people with symptoms of respiratory diseases and other symptoms associated with hypersensitivity to abacavir, even if alternative respiratory diagnoses (pneumonia, bronchitis or flu-like illness) are possible. If the symptoms of the illness cannot be clearly differentiated from a hypersensitivity reaction, abacavir should be permanently discontinued. Abacavir should not be restarted following a hypersensitivity reaction because more severe symptoms will recur within hours and may include life-threatening hypotension (decrease in blood pressure) and death.


Efavirenz and Marijuana Tests

One complication of taking efavirenz (Sustiva) is that some people may have a false positive test for marijuana when drug-screening tests are used. These tests can detect chemicals found in marijuana that are released into urine. According to DuPont Pharmaceuticals, the manufacturer of efavirenz, a confirmatory test (using gas chromatography) will clear up the matter by revealing the presence of efavirenz and not the chemicals found in marijuana.

The wide scale availability of the genotypic resistance test has raised the issue about the proper interpretation of those results. Genotypic resistance examines samples of the virus from a person and looks for the presence of specific mutations that are known to be associated with resistance to certain drugs. Most reputable laboratories will include interpretation of the results, which is based on the most recent findings and usually developed with the help of a group of resistance experts not affiliated with the laboratory. Unfortunately there are also some laboratories that claim to offer expert interpretation of the results but have had a poor history of actually doing so. Some of the more reputable laboratories include:

  • LabCorp/Virco

  • Stanford

  • Visible Genetics


First-Ever Testosterone-Replacement Gel Approved by FDA

AndroGel, a new testosterone-replacement therapy approach developed by Unimed Pharmaceuticals, Inc., has been approved by the Food and Drug Administration (FDA) for men with conditions associated with low testosterone levels.

AndroGel is a clear, colorless, topical (applied to the skin) gel that is applied once daily to shoulders, upper arms and/or abdomen (stomach area). It works similar to the testosterone patch. AndroGel has been shown to be effective in raising testosterone levels in men with low levels of this hormone. In one study, normal testosterone levels were reached within four hours of starting therapy. The gel appears to be able to sustain normal testosterone levels with continual use. (One study suggests that 87% of volunteers maintained testosterone levels within normal ranges through the last day of a 180-day treatment trial.)

AndroGel also appears to have the following beneficial effects associated with the biological function of testosterone:

  • Increases total body and total body lean mass (muscle mass)

  • Decreases total body fat

  • Increases bone density

  • Increases libido

  • Positive effects on mood and fatigue
This gel can be applied at home, as opposed to injectable testosterone which sometimes requires doctor visits for injection, increasing ease of use for some people. It appears that AndroGel is absorbed into the skin well and quickly.

An interesting property of AndroGel is that, when treatment is stopped after achieving normal levels of testosterone, testosterone levels remain in the normal range for 24-48 hours (but return to pretreatment levels by the fifth day after the last application). This means that an individual may miss an occasional dose or two without compromising their therapy.

This therapy differs from other topical therapies (like "compounded" creams) because it is FDA-approved and applied only once a day. Compounded gels and creams have not been through thorough lab testing and must be applied twice a day. (A "compounded" cream is mixed up by a pharmacist who has special equipment.) Also, there may be some variability in the compounded creams you can get in pharmacies, and some doctors are unfamiliar with how to write prescriptions for compounded products. AndroGel may alleviate these problems by providing an alternative to compounded creams and gels.

Unfortunately, these characteristics of AndroGel may not make up for some of its significant shortcomings. Though Unimed claims that their product is better absorbed into the body than compounded creams and gels, research shows that they are generally absorbed to about the same extent. When this is compared to the relative price of each therapy option (estimated to be about $75/month for AndroGel and about $17/month for compounded creams and gels), the types of advantages that this product has over compounded creams may not be worth the considerable price difference for many people.

Since skin remains exposed after AndroGel treatment, there are a few precautions that need to be taken for those using the therapy. First, people must be careful not to spread the gel from their hands or bodies to untreated individuals, especially women. (This is because women, when exposed to higher-than-normal levels of testosterone may develop secondary "male" characteristics including excessive facial and body hair.) Furthermore, extreme care should be made not to spread gel to pregnant women since testosterone is known to harm a developing fetus. Washing your hands after applying AndroGel and covering treated areas of the skin with clothing (once the gel has dried) will greatly reduce the likelihood of spreading the gel to another person.

Second, people may be forced to alter their lifestyle since they are advised to let the gel dry a few minutes before dressing and to wait five to six hours before showering or swimming so that it is properly absorbed. Another disadvantage is that gynecomastia (excessive development of the male breasts) frequently develops and occasionally persists during AndroGel therapy. In very rare cases, fluid build-up in certain tissues, possibly compounded with congestive heart failure, may be a serious complication in men with pre-existing heart, kidney, or liver conditions.

Also, AndroGel should be used with great caution among people who have one or more cancerous tumors in their breasts or have (or are suspected to have) one or more cancerous tumors in their prostate. Elderly men who use this gel may be at an increased risk for developing prostate cancer. AndroGel has not been adequately tested in women, but certainly women with cancer should use hormonal products with extreme care. However, the concerns about prostate and breast cancer apply to any therapy with any male sex hormone and are not entirely unique to AndroGel. AndroGel should be administered very cautiously if an individual also takes corticosteriods. Finally, AndroGel has not been studied, and thus not been approved for use, in men under 18 years of age. It has also not been well studied in women, though it is likely that women may consider using the product when appropriate.

AndroGel should be applied to clear, dry skin on the shoulders, upper arms, and/or abdomen once a day, preferably in the morning. AndroGel should not be applied to the genitalia. The recommended starting dose of AndroGel 1% is 5 G (to deliver 50 mg of testosterone). Blood testosterone levels should be measured approximately 14 days after starting therapy to make sure you have the proper dose. If the 5 G dose is too little, a 7.5 G and a 10 G dose are also available. AndroGel will be available in pharmacies around the middle of this year.

The most common immediate side effects (occurring in no more than 6% of the people studied) included: acne, application site reaction, headache, hypertension (high blood pressure), abnormal liver function tests, and non-cancerous prostate disorder. The most common long-term side effects (occurring in no more than 20% of people studied) included: abnormal liver function tests, acne, application site reaction, and prostate disorder (rarely cancerous).

The reported skin reactions at the application site were not severe enough to require treatment or stopping the drug. About 4% of people studied had reactions to AndroGel that required them to stop treatment.





  
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This article was provided by Project Inform. It is a part of the publication What's New. Visit Project Inform's website to find out more about their activities, publications and services.
 

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