1997

Sometimes Less is More
Treatment Issues - Volume 11, Number 11; November 1997
Jill Cadman
At this year s Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) a recurring theme was the difficulty patients have in adhering to complicated drug regimens and how noncompliance frequently leads to drug failure. Although this problem is multifaceted, involving emotional and psychological issues,


HIV Resurrection
Treatment Issues - Volume 11, Number 11; November 1997
Dave Gilden
The overarching AIDS image from this year s Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, held in Toronto from September 28 to October 1) was a huge slide projection of a cell bursting forth with HIV displayed during Robert Siliciano s keynote address. This was not just any HIV-infected CD4 c


Three Drugs Now in Expanded Access
Treatment Issues, Vol 11, No 10; October 1997
Dave Gilden
As expected, Gilead Sciences has announced the start up of an expanded access program for its experimental anti-HIV agent adefovir (which now has a brand name -- Preveon). Formal physician registration will probably begin in early November, after the FDA completes its review of the program s particulars.


FDA Reform Sails Through Congress
Treatment Issues, Vol 11, No 10; October 1997
Derek Link
Last month, the House of Representatives and the Senate both overwhelmingly passed bills to reform the Food and Drug Administration. The vote on the House measure (HR 1411) was unanimous while the Senate passed its bill (S.830) by a 98 to 2 margin. Senator Edward Kennedy, D-MA, and Senator Jack Reed, D-RI, were the onl


Group Therapy for Depression
Treatment Issues, Vol 11, No 10; October 1997
The National Institute of Mental Health is enrolling a study on women and depression in New York, New Jersey and Florida. The study, called the Smart/EST Women s Project, is designed to evaluate the benefit of supportive therapy interventions on quality of life and health status in a group of ethnically diverse women w


Meeting the Challenge of Depression in HIV
Treatment Issues, Vol 11, No 10; October 1997
Judith G. Rabkin, Ph.D., Department of Psychiatry, Columbia University College of Physicians and Surgeons
Both doctors and patients often assume that people with serious and progressive illnesses are likely to be clinically depressed, especially when they become very ill. However, findings from both cross-sectional and longitudinal studies of people with HIV illness contradict the notion that clinical depression is an inev


Presumptive TB Prophylaxis Rejected
Treatment Issues, Vol 11, No 10; October 1997
Gabriel Torres, M.D.
HIV-infected persons are estimated to be 100 times as likely as uninfected persons to have tuberculosis (TB). This is mainly due to reactivation of a latent infection with Mycobacterium tuberculosis. Reactivation of TB occurs in about 7% to 10% of persons who have positive tuberculin skin tests every year. Isoniazid (I


Optimizing PCP Therapy
Treatment Issues, Vol 11, No 10; October 1997
Gabriel Torres, M.D., and Jill Cadman
Much needed research to determine the best prophylactic regimen for Pneumocystis carinii pneumonia has been on going in the form of clinical trials. In the past few months, two important conferences, the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the Infectious Disease Society of Ameri


Half-full or Half-empty: No Simple Answer on Protease Inhibitor Failure
Treatment Issues, Vol 11, No 10; October 1997
Gabriel Torres, M.D.
The 37th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) was held September 28 - October 1, 1997 in Toronto. The meeting included presentations on a wide array of new information about HIV and opportunistic infections, much of it in highly preliminary or incomplete form. Several such ear


Vitamin B12 and Cognitive Impairment
Treatment Issues, Volume 11 Number 9; September 1997
Alan Huff, D.C.
A study by the Johns Hopkins University component of the Multicenter AIDS Cohort Study (MACS) followed B vitamin blood levels in 310 HIV-positive men for nine years. In a report last winter,1 the MACS investigators noted that those with abnormally low serum levels of cobalamin (B12) in their blood progressed to AIDS al


Antioxidants may still have a Role in HIV Treatment
Treatment Issues, Volume 11 Number 9; September 1997
Gina Chan, M.S., R.D./C.D.N. and Jeannie Collins, M.P.H., R.D./C.D.N., Tim Horn also contributed to this report.
Antioxidant nutritional supplements such as vitamins A, C and E have enjoyed great popularity among people with HIV and AIDS for most of the epidemic. That popularity has endured despite continuing confusion about antioxidants mode of action, effectiveness and safety. In the new era of highly active antiretroviral ther


DMP 266 Now Available
Treatment Issues, Volume 11 Number 9; September 1997
Dave Gilden
DuPont Merck s potent new non-nucleoside reverse transcriptase inhibitor DMP 266, now called Sustiva or efavirenz , will be made available in October through a limited expanded access program. To be eligible for the program, individuals must have had a CD4 count of l


CMV Trials Struggle to Enroll
Treatment Issues, Volume 11 Number 9; September 1997
Jill Cadman
Due to the new anti-HIV therapy options that have at least temporarily improved the clinical course of HIV/AIDS, trials of experimental treatments for HIV and opportunistic infections (OIs) have been unexpectedly slow to accrue participants. Even if willing to volunteer, many persons with HIV or AIDS no longer meet the


IL-2 for HIV: The Long March Toward FDA Approval
Treatment Issues, Volume 11 Number 9; September 1997
Craig Sterritt
Interleukin-2 ( IL-2 ), a candidate immune-based therapy for HIV disease, is now at a pivotal stage in its development. (See Treatment Issues, November 1996, pages 1-5, for IL-2 s history as an experimental treatment for HIV/AIDS.) Researchers are finally starting up a massive phase III trial to determine once and for


Pain Management in Children with HIV/AIDS
Treatment Issues, Vol 11, No 7/8; July/August 1997
Mary Jo O'Hara, R.N., and Lynn Czarniecki, R.N., National Pediatric & Family HIV Resource Center, University of Medicine and Dentistry of New Jersey
A five- year-old boy enters the hospital and remains curled in a fetal position, face to the wall, refusing to talk. Medical interventions to treat the reason for the admission are instituted, but the child remains withdrawn. Given the stage of illness, a trial of round-the-clock pain medication is given, and he begins


Treating Children for HIV and AIDS
Treatment Issues, Vol 11, No 7/8; July/August 1997
Karin Nielsen, Pediatric Infectious Disease Specialist, UCLA Maternal Child Clinic
With the advances in the field of HIV retrovirology, new treatment options and new diagnostic resources are now available for pediatric patients. Management of the HIV-infected child is an evolving process with a rapidly changing prognosis. It seems clear that HIV-infected children can obtain significant benefit from h


ACTG 300 Leaves Many Questions Unanswered
Treatment Issues, Vol 11, No 7/8; July/August 1997
Dave Gilden
On June 18, the NIH-sponsored pediatric trial ACTG 300 was brought to an early conclusion. Its Data and Safety Monitoring Board (DSMB) had determined that the data already collected amply demonstrated that AZT / 3TC , or AZT/ddI for that matter, were superior to ddI mo


Early Treatment for HIV-Infected Infants
Treatment Issues, Vol 11, No 7/8; July/August 1997
Jill Cadman
With increased screening of pregnant women, many fetuses are known to be at risk for HIV infection. Therefore, infants born to HIV-infected women can be checked within the first weeks of life by PCR or culture assays for the presence of infectious virus in blood specimens. HIV infection can be definitively diagnosed in


Rapid Advances in Preventing Vertical Transmission
Treatment Issues, Vol 11, No 7/8; July/August 1997
Jill Cadman
The decision to have a child can be a complicated one under any circumstances, but for an HIV-positive woman it may well be the most difficult decision she will ever face. Being HIV-positive does not automatically supplant the maternal instinct and the desire to have children. As new AIDS treatments are proving more su


HIV Risks in Women Who Have Sex with Women
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
In 1995, the Centers for Disease Control (CDC) called a meeting of lesbian HIV experts to request input on policy, prevention and outreach to women who have sex with women (WSW). An article written by CDC staff members (Meaghan Kennedy, Margaret Scarlett, Ann Duerr and Susan Chu) in the May/August 1995 issue of the Jou


Commentary Postexposure Antiretroviral Treatment for Rape Survivors?
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg RN, FNP, MSN
The probability of HIV infection from a single needlestick exposure is considered to be 0.32%. A single sexual exposure to HIV through a mucosal surface (vagina or rectum) may pose a similar probability for HIV infection. In The New England Journal of Medicine (April 10, 1997), a Sounding Board editorial examined the q


Childhood Sexual Abuse as an HIV Risk Factor in Women
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
In doing HIV/AIDS work, it is critical to operate with the awareness that a large proportion of adolescents and adults were sexually abused as children and that abuse has had a profound and devastating effect on their consequent psychosocial development. Childhood sexual abuse has been strongly associated with numerous


Woman-Initiated Methods for HIV Prevention
Treatment Issues, Vol 11, No 7/8; July/August 1997
Zena Stein, M.A., Columbia University HIV Center
Avoiding sexually transmitted diseases (STDs), including HIV, can be more complicated for women than for men. The circumstances under which women have sexual encounters with partners vary both with their own demographic background (age, culture, religion, socioeconomic status, sexual preference, etc.) and also with the


Pelvic Inflammatory Disease in HIV Infection
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
At the National Conference for Women and HIV (May 4-7, Pasadena, CA) there were two presentations on pelvic inflammatory disease (PID) in HIV infection. Ann Duerr (of the CDC) presented a state-of-the-art lecture on gynecologic infections at 8:30 on Tuesday morning. The audience, especially women living with HIV, was r


Candidiasis in Immune-Compromised Women
Treatment Issues, Vol 11, No 7/8; July/August 1997
Jill Cadman
Candidiasis refers to any infection caused by a group of yeast-like fungi called Candida. Candida albicans is the most common type and is normally found in the mouth, digestive tract, vagina and skin of a healthy person. The presence of Candida does not always lead to a flare-up, but in some people can cause recurrent,


Cervical Cancer and Women with HIV
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
Cervical cancer is a preventable condition, and when diagnosed early, it can be cured. Deaths from cervical cancer have gone down by 70% in the U.S. since 1943, when routine Pap smears were introduced for sexually active women. Pap smears consist of a sample of cells scraped from the cervix and examined under a microsc


HIV and the Vaginal Ecosystem
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
The vagina, as a potentially healthy structure that can defend against invasion by HIV and other pathogens, received appropriate recognition at the May 1997 National Conference on Women and HIV. Penelope Hitchcock, D.V.M., of the National Institutes of Health gave a state-of-the-art lecture, The Vaginal Ecosystem: Natu


HIV's Impact on Women's Physique
Treatment Issues, Vol 11, No 7/8; July/August 1997
Dave Gilden
Women and men obviously differ in many ways besides sex organs. Differences in the effects of sex hormones result in men being on average more muscular compared to women of the same height and exercise patterns. This contrast in body composition is of particular interest for AIDS and HIV infection. Response to disease


Office on Women's Health Finally Gets Around to HIV
Treatment Issues, Vol 11, No 7/8; July/August 1997
Saundra Johnson
On July 8, 1997, the U.S. Public Health Service s Office on Women s Health finally developed a formal interest in women and HIV disease. Approximately 60 women attended the July meeting either in person or via the telephone. The goal of the gathering was to address issues that contributed to the 3% increase in the wome


Women's Natural History Studies
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
Much of what is known today about HIV/AIDS was learned from long-term natural history studies of gay men, such as the Multicenter AIDS Cohort Study ( MAC ) and the San Francisco Gay Men s Health Study. Current understanding of modes of transmission, biologic cofactors, behavioral cofactors, acute HIV infection, progres


HIV Infection in Women: Still Untreated, Still Deadly
Treatment Issues, Vol 11, No 7/8; July/August 1997
Risa Denenberg, R.N., F.N.P., M.S.N.
HIV infection is now the leading cause of death for women 25 to 44 years old in New York City. The same is true for 25- to 44-year-old African-American women across the United States . At the same time, deaths among all persons with AIDS substantially decreased last year, both in New York City and nationally. (Accordin


Treatment Briefs: Marijuana's Ups and Downs in California
Treatment Issues, Vol 11, No 4/5; April 1997
David Gilden
An April 21 early morning raid by federal narcotics agents netted over 300 marijuana seedlings at Flower Therapy, one of the San Francisco medicinal marijuana distribution centers that serve people with AIDS. Flower Therapy was trying to operate under the umbrella of California Proposition 215, which state voters passe


Treatment Briefs: Some Competition for 1592
Treatment Issues, Vol 11, No 4/5; April 1997
David Gilden
**DMP 266: DMP 266 is Du Pont Merck s experimental nonnucleoside reverse transcriptase inhibitor. In an initial, trial of low-dose DMP 266 (200 mg once a day) plus indinavir , viral loads were 2.5 logs (99.7%) below baseline at 42 weeks, with 80% of the 21 participants below the viral load assay s level of detection (4


Treatment Briefs: Glaxo's Parsimonious Compassion
Treatment Issues, Vol 11, No 4/5; April 1997
David Gilden
1592U89 is a new nucleoside analog from Glaxo Wellcome that promises to be a marked improvement over present analogs such as d4T or 3TC . In early trials, it was shown to reduce HIV viral loads on its own by up to 1.


No Attrition in Research on Wasting Therapies
Treatment Issues, Vol 11, No. 4/5; April 1997
Dave Gilden
One of the most prevalent and dangerous conditions in AIDS and HIV disease has been chronic wasting, in which people progressively become so depleted of lean tissue and protein stores that their bodies can no longer perform basic functions. In this new era of highly active antiretroviral therapy (HAART), is it still a


Roche Brings New Formulation of Saquinavir To FDA
Treatment Issues, Vol 11, No. 4/5; April 1997
Jill Cadman
On May 12, Hoffmann-La Roche announced that it was applying to the FDA for approval of the long awaited soft gelatin capsule formulation of saquinavir . The soft gel capsule contains the protease inhibitor saquinavir blended with a proprietary lipid mixture that rais


SPV-30 Promos Nixed by FDA
Treatment Issues, Vol 11, No 4/5; April 1997
Dave Gilden
It s banned -- no, it s just warned -- wait a minute, the crisis is over. This spring was a controversial one for SPV-30, an extract of the European boxwood tree made by the French company Arkopharma. SPV-30, which reputedly has anti-HIV properties, is sold here by some AIDS buyers clubs and a few pharmacies. For a tim


Happiness Reigns in the Drug Marketplace
Treatment Issues, Vol 11, No. 4/5;- April 1997
Karen Kuller
A new trend is changing the face of AIDS. Increasingly, information on HIV treatment options is gaining exposure through drug companies marketing tactics -- specifically, mass-advertising. A two-page ad in this month s issue of GQ depicts a mountain-climber who struggles to make his way up a rocky cliff, and ends up on


Roche Puts Ganciclovir Prodrug Program On Hold
Treatment Issues, Vol 11, No. 4/5; April 1997
Jill Cadman
The current oral and intravenous formulations of ganciclovir call for arduous dosing regimens. Long-term treatment with these compounds is difficult and compliance can be problematic. Improved versions of ganciclovir are imperative. Roche s ganciclovir prodrug (RS 79070) would represent a significant improvement, requi


Now There are Eleven, but So What?
Treatment Issues, Vol 11, No 4/5; April 1997
Dave Gilden
With the April 7 FDA approval of Pharmacia & Upjohn s delavirdine (brand name: Rescriptor ), there are now 11 drugs marketed in the U.S. for suppressing HIV. Delavirdine , like


Ganciclovir Implants: One Year Later
Treatment Issues, Vol. 11, No. 4/5; April 1997
Jill Cadman
Chiron Vision s Vitrasert eye implant for treating CMV was approved by the FDA in March of 1996 (see Treatment Issues article CMV: The Other Virus , March 1996, pages 10-11). The implant is an important breakthrough because it is able to deliver steady amounts of ganciclovi


CMV ABCs
Treatment Issues, Vol 11, No. 4/5; April 1997
Jill Cadman
CMV ( cytomegalovirus ) is a prevalent virus from the herpes family which can cause opportunistic infections in immune-compromised persons. It is estimated by the Centers for Disease Control (CDC) that one-third of all Americans are infected with CMV. The virus is transmitted through body fluids or transfusions.


Treatment Briefs: Viral Load Patient Assistance Programs
Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden
Both Chiron and Roche have set up patient assistance programs (PAP) to ensure there is access to viral load tests for those who have no current means of payment. The number to call for information (in English or Spanish) for the Roche program for PCR tests is (888) TEST-PCR. The PAP representative will first determine


Treatment Briefs: More Pharmacies to Carry Crixivan
Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden
Since indinavir ( Crixivan ) entered the market in March, 1996, its manufacturer, Merck & Co. , has given the mail-order Stadtlander s Pharmacy exclusive distribution rights in order to manage the limited supplies available. This was to be a temporary situation until Merck was able to bring new production fa


Treatment Briefs: Ritonavir Approved for Children
Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden
The FDA also granted approval for a pediatric ritonavir formulation on March 14. In so doing, the agency increased the number of protease inhibitors available for children from zero to two in one day (see above for nelfinavir).


A NAC for Controversy
Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden and Jill Cadman
The role of nutrition and vitamin supplementation in treating diseases has always been controversial. This month and next, we will examine the class of compounds known as antioxidants and the role they may play in slowing HIV disease progression. While some reports have come to negative conclusions, many others have su


Spring Cleaning in Trial Land
Treatment Issues, Vol 11, No 3; March 1997
Dave Gilden
In the past month, investigators shut down three major indinavir trials earlier than planned. The implications of these trials striking results, so clear-cut that they made further follow-up superfluous, go beyond the use of indinavir-containing regimens. Ending trials early says that the answers to questions the trial


Some Relief from the Epidemic
Treatment Issues, Vol 11, No 3; March 1997
Jill A. Cadman
Authorities from a wide variety of sources, international, national and local, are reporting that death and hospitalization rates for persons with AIDS dropped sharply in 1996. Medication to treat or prevent opportunistic infections, increased utilization of medical care and combining nucleoside analogs are the reasons


Searching for Synergy: An Interview with Erik De Clercq
Treatment Issues, Vol 11, No 2; February 1997
Gabriel Torres, M.D.
Professor Erik De Clercq, M.D., Ph.D., is one of the pioneers of antiviral research. From his base at the Riga Institute of Medical research in Leuven, Belgium , he has directed a team that made many of the original discoveries in anti-HIV medications. Prof. De Clercq is best known for opening up the field of nucleotid


Nevirapine Protects Chimpanzees
Treatment Issues, Vol 11, No 2; February 1997
Gabriel Torres, M.D.
A study presented by Boeringher Ingelheim at the Retrovirus Conference (abstract 728) evaluated the protective effect of the company s NNRTI nevirapine ( Viramune ) in chimpanzees. Chimps are the only other primate that can be infected with HIV-1, although it does not


Dethroning AZT
Treatment Issues, Vol 11, No 2; February 1997
Dave Gilden, with John Falkenberg and Gabriel Torres, M.D.
Several trials announced last year found that AZT added little when included in two drug regimens. Among these were ACTG 175 and the pediatric trial ACTG 152, both of which found ddI monotherapy and ddI plus AZT to be equivalent or superior to AZT alone. Company trials of


Protease Inhibitors: Resistance, Resistance, Resistance
Treatment Issues, Vol 11, No 2; February 1997
Dave Gilden, with John Falkenberg and Gabriel Torres, M.D.
Nothing at the Retrovirus Conference changed the fact that all the HIV drugs now available or in advanced development operate by interfering with either HIV s reverse transcriptase or protease enzymes. Protease inhibitors are potent drugs in their own right, and combining them with reverse transcription inhibitors make


Commentary: A Retro Retrovirus Conference
Treatment Issues, Vol 11, No 2; February 1997
Dave Gilden
The Fourth Retrovirus Conference was marked by authoritarianism and unpleasantness. A multitude of guards and rules greeted Conference goers. Seventeen activists who arrived unregistered were not allowed in; pharmaceutical marketing representatives who tried to give up their registrations in favor of community physicia


Somewhere over the Rainbow . . . Right?
Treatment Issues, Vol 11, No 2; February 1997
Dave Gilden
. . . lies the cure for AIDS. But you wouldn t find it at the fourth annual Conference on Retroviruses and Opportunistic Infections (held in Washington, D.C., on January 22-26). Although not heralding any new breakthroughs, the Conference reflected the gradual accretion of promising developments leading toward fulfilli


Commentary: Reinventing Expanded Access
Treatment Issues, Vol 11, No 1; January 1997
Theo Smart
Less than ten months after the approval of indinavir and ritonavir , a sizable number of people have already failed on these purported wonder drugs. Oh, there may be one or two antiretrovirals left that they have not taken, but given HIV s facility for mutating to ac


HIV/AIDS-Related Fatigue
Treatment Issues, Vol 11, No 1; January 1997
Lillian Delmonte, D.Sc.
Fatigue impacts significantly on the psychological well-being and quality of life of patients with HIV/AIDS, says William Breitbart, M.D., attending psychiatrist and director of Clinical Care Training for the Psychiatry Service Memorial Sloan-Kettering Cancer Center in New York City. Fatigue, generally measured by pat


Contradictory Roles for GM-CSF
Treatment Issues, Vol 11, No 1; January 1997
Theo Smart
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is used to raise low neutrophil cell counts (neutropenia), a frequent drug- or AIDS-related condition that impairs the body s ability to ward off infection. But there have been reports that GM-CSF increases HIV activity as well as boosting cell proliferation. Su


NIH Panel Examines Consequences of AZT in Pregnancy
Treatment Issues, Vol 11, No 1; January 1997
Saundra Johnson
Conflicting data from two studies of AZT s ability to induce tumors in mice exposed to the drug before birth has raised considerable consternation and confusion at the National Institutes of Health (NIH). Since 1994, the Public Health Service (PHS) has advised administering AZT to pregnant HIV- positive women and their


Medical Marijuana: Research Priority, Hoax or Civil Right?
Treatment Issues, Vol 11, No 1; January 1997
Elisa H. Nelan
Medical marijuana, long a subject of interest to HIV-affected persons, has become the subject of broader national interest since the elections last November and the passage of two key voter initiatives, Propositions 215 and 200 in California and Arizona, respectively. The propositions reflect popular belief that anecdo



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©1980, 1997. AEGiS.