2000

RITA! December - Volume 6, Number 4

Letter from the Editor
Thomas Gegeny, MS, ELS
Everyone has trouble sleeping at one time or another. Anxiety the night before an important presentation or exam, stress about personal or financial matters, or even too much television or caffeine before bed can cause trouble sleeping. But insomnia is a different phenomenon, involving a disturbance in the sleep cycle that lasts over a period of time. This disturbance itself can induce stress, further masking the original cause(s) of sleeplessness.

FOR THE CLINICIAN: Insomnia in HIV and its management: one clinician's perspective
Zishan Samiuddin, MD, Baylor College of Medicine
This article is a practical, precise and concise overview of my 7.5 years of experience treating a broad range of sleep problems in a heterogeneous group of HIV-infected individuals at the Thomas Street Clinic (TSC) in Houston. TSC is a community-based clinic that provides primary medical care to the indigent HIV/AIDS community.

FOR THE CLINICIAN: Oral hairy leukoplakia: an Epstein-Barr virus-associated disease of patients with HIV
Dennis M. Walling, MD, The University of Texas Medical Branch at Galveston
Epstein-Barr virus (EBV) is a ubiquitous human herpesvirus that infects nearly every human being by young adulthood. Most EBV infections occur asymptomatically during childhood, but EBV is associated with a wide variety of human diseases including the infectious mononucleosis syndrome, Hodgkin's lymphoma, African Burkitt's lymphoma and nasopharyngeal carcinoma. EBV is also an opportunistic pathogen in immunocompromised patients, associated with lymphoproliferative diseases and oral hairy leukoplakia.

DRUG FACT SHEET: Lopinavir/ritonavir (Kaletra)
On September 15, 2000, the US Food and Drug Administration (FDA) granted Abbott Laboratories accelerated approval for the marketing of Kaletra (lopinavir/ritonavir), making it the seventeenth agent licensed for the treatment of HIV infection. The FDA based its approval on the results of 3 surrogate marker studies.

CLINICAL QUERIES
HIV-treating physicians in Houston express their professional opinions on the public health implications of antiretroviral therapy

THINK ABOUT IT: Remune rejected. (Will a manual recount be required?)
L. Joel Martinez
In a scenario reminiscent of the 2000 presidential election, The Immune Response Corporation (IRC) tried unsuccessfully to block the publication of the results of Study 806, a study aimed at assessing whether Remune (also known as the Salk vaccine or HIV-1 immunogen) in combination with antiviral drugs could keep persons healthy for a longer period of time than antivirals alone.

THINK ABOUT IT: HIV drug resistance testing: data be damned
HIV's ability to develop drug resistance, through rapid turnover and high rates of mutation, has been the Achilles' heel of antiretroviral therapy. On a molecular level, HIV's mechanism of replication is error prone and given to genetic infidelity. But on a therapeutic level, haphazard viral reproduction is the bane of anti-HIV drugs.





RITA! September - Volume 6, Number 3

Letter from the Editor
Thomas Gegeny, MS, ELS
The now-familiar acronym "HAART" stands for highly active antiretroviral therapy. It is a strategy for treating HIV/AIDS built on the use of 3 or more anti-HIV drugs in the hope of halting disease progression by hindering viral replication.

THINK ABOUT IT: Arriving too soon: suggestions for the coming generation of "heavily treated" patients
Paul Simmons, RN, ACRN
You don't know it yet, but you will read about yourself in the pages of POZ or elsewhere, and you'll do it soon. No, the authors won't refer to you by name. But here's the clue that it's you they're writing about: look for the phrase "heavily treated patient." You may not know exactly what that means. But you will probably have a vague sense, reading terms like "salvage" and "rescue," that trouble is near.

THINK ABOUT IT: Protease inhibitors: opium of the masses?
L. Joel Martinez
The development of protease inhibitors (PIs) dramatically changed the landscape of HIV/AIDS treatment. Morbidity and mortality among HIV-infected persons decreased. This much is undeniable.

SIMPLY STATED: Surviving with HIV in the HAART era: emerging challenges
Thomas Gegeny
Even though highly active antiretroviral therapy (HAART) has helped many keep HIV disease at bay, HIV-infected persons must not become complacent by equating good health with undetectable viral loads and CD4 T cell counts above 200 cells/mm3. It has become increasingly, if not painfully, apparent that other risks exist with the potential of causing serious complications or even death. If only all that was required was to achieve and maintain an undetectable viral load.

FOR THE CLINICIAN: Systemic non-Hodgkin's lymphoma in persons with HIV-infection
Regis Vilchez, MD, & Janet S. Butel, PhD, Baylor College of Medicine & Baylor Center for AIDS Research
The management and therapy of patients with HIV infection has improved in the past few years as a result of major advances in antiretroviral therapy. However, despite these advances and perhaps as a result of longer survival, some of the oncologic complications of HIV infection remain important.

FOR THE CLINICIAN: Oral warts in HIV-infected individuals
Sandra Felefli, DDS, MS, & Catherine M. Flaitz, DDS, MS, The University of Texas at Houston Health Science Center, Dental Branch
Oral diseases are common manifestations of HIV infection, with up to 90% of HIV-infected patients developing an oral lesion through the course of their HIV disease. Oral candidiasis, aphthous-like ulcerations, periodontal infections, salivary gland diseases, various malignancies and numerous viral opportunistic infections have been described in the oral cavity of HIV-infected patients.

CLINICAL QUERIES: Three HIV-treating physicians express their professional opinions regarding a case scenario
A 47-year-old Hispanic male, 5'7" and 132 pounds, presents for follow-up. He is on his third regimen. His nadir CD4 T cell count was 10 cells/mm3. Prior genotypic tests show resistance to indinavir (Crixivan), ritonavir (Norvir) and saquinavir (Fortovase) and resistance to all nucleosides except stavudine (Zerit).

CLINICAL SCIENCE: Report from the 4th International Workshop on HIV Drug Resistance and Treatment Strategies
William O'Brien, MD, MS, The University of Texas Medical Branch at Galveston
The 4th International Workshop on HIV Drug Resistance and Treatment Strategies was held in Sitges, Spain. This fairly exclusive meeting was limited to investigators who were primary authors on accepted abstracts, workshop organizers and a few representatives from industry sponsors. The meeting is held annually in the early summer, so that every other year it precedes the International AIDS Conference.

INTERVIEW: A look at HIV immune research
Although viral load testing is the standard for measuring the effectiveness of antiretroviral therapy, it is at best an indirect measure of changes in the immune system. Several assays are now in development that measure cellular immune response. These tests could lead to better ways of evaluating the clinical status of the immune system and provide greater insight into the mechanisms of immune reconstitution. Recently Alan Huff, a Houston HIV/AIDS activist, interviewed Alan Landay, PhD, about new developments in this area. Landay is a Professor of Immunology/Microbiology at Rush Medical College in Chicago.

NEWS BRIEFS
Dose frequency warning for didanosine (Videx). In October 1999 the US Food & Drug Administration (FDA) approved once daily dosing for Videx brand didanosine. The agency did so on the basis of a 24-week interim analysis of randomized trial BMS 148 comparing once-daily didanosine plus stavudine (Zerit) and nelfinavir (Viracept) to zidovudine, lamivudine (Epivir) and nelfinavir.

RITA! June - Volume 6, Number 2

Letter from the Editor
Thomas Gegeny, MS, ELS
In recent months, AIDS coverage by the media has taken a turn. In addition to news covering the struggles with vaccine development or the advantages and disadvantages of various drug therapies, several other themes have cropped up: the politics of AIDS, the economics of AIDS, the ethics of AIDS.

Uncle Sam wants you: Federal HIV research finally comes to Houston

Houston is the fourth largest city in the United States and ranks seventh in number of AIDS cases. Still, 20 years after the start of the epidemic, the Bayou City had yet to launch a functioning, federally funded adult HIV clinical trials unit. In the mid-1980s, Houston was awarded government funds to participate in what is now the adult AIDS Clinical Trials Group (ACTG).

IN DEVELOPMENT: Katy, bar the door! HIV entry inhibitors
L. Joel Martinez
HIV replication requires the virus to enter human cells and become integrated into cellular DNA. Similarly, currently approved drugs must also enter those cells to provide a therapeutic effect. Perhaps because this battle between virus and drugs rages at a cellular level, patients and doctors have long anticipated the emergence of long-term side effects.

BASIC SCIENCE - Long-term nonprogressors: the study of HIV infection without progression to AIDS
Thomas Gegeny
Although the past decade has seen great strides in the treatment of HIV, much about the virus remains obscure. Drug development to date has mainly followed from research characterizing the life cycle of HIV (for instance, targeting viral reverse transcriptase or protease enzymes to interrupt viral replication).

BASIC SCIENCE - Immunopathogenesis of HIV infection: concepts and questions
Paul Simmons, RN, ACRN
HIV infection causes a primary immune deficiency, leaving the host vulnerable to an array of opportunistic pathogens and malignancies. Understanding the damage HIV does to the immune system has implications for both clinical care and laboratory research.

CLINICAL SCIENCE: How fourteen anti-HIV drugs could provide more bang for the buck
L. Joel Martinez
Controlling HIV, at least in the short run, requires that persons infected with the virus be fully suppressed or so goes the theory. Yet the point of suppression keeps moving with time. In the early days of viral load using bDNA (branched DNA), patients were told that a viral load of less than 10,000 copies/mL constituted an undetectable viral load.

RITA! March - Volume 6, Number 1

Letter from the Editor
Thomas Gegeny, MS, ELS
Where do you want to go today? Specifically, what treatment options are out there for you, your clients, or your patients? Most regimens have side effects that, for some, outweigh the benefits.

HIV/AIDS Research & Treatment Timeline 1999



DATA SETS ...from the 7th Conference on Retroviruses & Opportunistic Infections, 2000

Several studies investigated primary HIV infection (PHI) in an attempt to characterize the immune response and the effects of antiretroviral intervention during this early phase of infection. One group measured levels of HIV RNA in oral fluids, genital secretions, peripheral blood, and cerebrospinal fluid from subjects with PHI (Abstract 556).

Drug Fact Sheets

About the Drug Fact Sheets

This issue's drug fact sheets summarize the currently approved drugs indicated for the treatment of HIV infection. The drugs are grouped according to class: nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors. Within each class, the drugs are listed in the order of approval by the US Food and Drug Administration.

NRTI: ZIDOVUDINE (Retrovir)

Zidovudine was approved by the US Food and Drug Administration (FDA) in March 1987 as the first antiretroviral to treat HIV disease. The drug is manufactured and distributed by Glaxo Wellcome. Zidovudine is a nucleoside reverse transcriptase inhibitor (NRTI).

DIDANOSINE (Videx)

Didanosine tablets are round and off-white to pale yellow-orange, with "Videx" on one side and the tablet strength on the other side. Didanosine is also available in a powder form for oral solution. Dosing may vary.

ZALCITABINE (Hivid)

When zalcitabine (Hivid) received marketing clearance from the US Food and Drug Administration (FDA) in June 1992, it became the first antiretroviral drug licensed under the accelerated approval process. The drug is produced by Hoffmann-LaRoche. Zalcitabine is a nucleoside reverse transcriptase inhibitor (NRTI).

STAVUDINE (Zerit)

Cleared for marketing by the US Food and Drug Administration (FDA) in June 1994, stavudine became the fourth agent available for the treatment of HIV infection and the second antiretroviral released under accelerated approval. Stavudine is a nucleoside reverse transcriptase inhibitor (NRTI).

LAMIVUDINE (Epivir)

Lamivudine received accelerated approval from the US Food and Drug Administration (FDA) in November 1995. The drug is manufactured and distributed by Glaxo Wellcome. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI).

ABACAVIR (Ziagen)

Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI). This drug is the most powerful in its class and one of the most potent antiretrovirals available. The US Food and Drug Administration (FDA) approved abacavir in December 1998. The drug is manufactured by Glaxo Wellcome. Abacavir is indicated in combination with other antiretrovirals for the treatment of HIV infection.

NEVIRAPINE (Viramune)

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc. and distributed by Roxanne Laboratories, Inc. Nevirapine was granted accelerated approval for use in combination with nucleoside reverse transcriptase inhibitors (NRTIs) by the US Food & Drug Administration (FDA) in June 1996.

DELAVIRDINE (Rescriptor)

Delavirdine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), manufactured by Pharmacia & Upjohn. Recently Agouron Pharmaceuticals acquired the commercial rights to delavirdine. The drug was granted accelerated approval for use with other antiretroviral drugs by the FDA in April 1997.

EFAVIRENZ (Sustiva)

The individuals who lead the Fair Price Working Group, as well as the individuals and organizations that are signatories to its consensus statement on the pricing of efavirenz, represent some of the most prominent and respected precincts of AIDS advocacy. Ninety-one organizations and 165 individuals have signed on to the Group's effort.

SAQUINAVIR (Fortovase or Invirase)

Participants who drank one glass of grapefruit juice with the saquinavir, and then another glass an hour later saw their AUCs (areas under the curve, a measure of the total exposure of the drug) increase 50 percent to 150 percent.

RITONAVIR (Norvir)

Ritonavir is a protease inhibitor. The US Food and Drug Administration (FDA) approved ritonavir in March 1996. Ritonavir is indicated in combination with other antiretrovirals for the treatment of HIV infection. The drug is manufactured by Abbott Laboratories.

INDINAVIR (Crixivan)

Indinavir is a protease inhibitor manufactured by Merck & Co., Inc. It was granted accelerated approval for use in combination with nucleoside reverse transcriptase inhibitors (NRTIs) by the US Food & Drug Administration (FDA) in March 1996.






This information is designed to support, not replace, the relationship that exists between you and your doctor.
©2000. ÆGIS.