MOTIV8 GLOSSARY

GLOSSARY

acute HIV infection

The period of rapid viral replication immediately following exposure to HIV. An estimated 80 to 90 percent of individuals with primary HIV infection develop an acute syndrome characterized by flu-like symptoms of fever, malaise, lymphadenopathy, pharyngitis, headache, myalgia, and sometimes rash. Following primary infection, seroconversion and a broad HIV-1 specific immune response occur, usually within an average of three weeks after transmission of HIV. It was previously thought that HIV was relatively dormant during this phase. However, it is now known that during the time of primary infection, high levels of plasma HIV RNA can be documented.

adherence

The extent to which the patient continues the agreed-upon mode of treatment or intervention as prescribed

alternative medicine

a term used to describe approaches to health care that are outside the realm of and are used in place of conventional medicine. Key questions exist as to whether they are safe or if they work. Examples include special diets, homeopathic remedies, electromagnetic fields, and therapeutic touch.

antibody

protein in the blood that are generated in reaction to foreign proteins. antibodies selectively neutralize the foreign proteins, producing immunity to certain microorganisms or their toxins. Tests to determine if you are HIV positive look for HIV antibodies -- evidence that your body is attempting to fight the virus.

antiretroviral

a substance that kills or suppresses a retrovirus, such as HIV. All of the anti-HIV drugs --AZT, Sustiva, Reyataz, Fuzeon, etc. -- are considered antiretroviral drugs.

baseline assessment

assessment of subjects as they enter a trial and before they receive any treatment.

bio-analytical assays

methods for quantitative measurement of a drug, drug metabolites or chemicals in biological fluids.

bioavailability

rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body.

CD4 count

the number of helper T-lymphocytes in a patient’s blood, usually expressed as the number of cells per cubic millimeter. When this value drops below 200, the patient has AIDS. Also called t-cell count.

combination therapy

using 2, 3, or more drugs at the same time. Studies have shown that taking multiple anti-HIV drugs is more potent than taking a single drug.

complementary medicine

a term used to describe approaches to health care that are outside the realm of and are used along with conventional medical treatment. The key issue is whether the complimentary treatment interferes with the patient's conventional medical treatment. Examples are diet and herbal supplements, aroma therapy, and massage.

compliance

Adherence to all the trial-related requirements, good clinical practice requirements and the applicable regulatory requirements.

confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

control group

the group of subjects in a controlled study that received no treatment, a standard treatment or a placebo.

cytomegalovirus (cmv, human herpes virus 5)

a herpes virus. CMV infection often occurs in healthy individuals without causing symptoms. In immunocompromised individuals (usually at CD4 counts below 50 cells/mm3), CMV may cause serious illness including retinitis (inflammation of the retina), pneumonia, colitis (inflammation of the large bowel) and encephalitis. CMV infection of a pregnant woman may lead to congenital abnormalities in the newborn. CMV may be treated with ganciclovir, foscarnet or cidofovir.

demographic data

characteristics of subjects or study populations, which include such information as age, sex, history of the disease for which they are being treated, and other characteristics relevant to the study in which they are participating.

DDC (zalcitabine, dideoxycytidine, hivid)

a nucleoside analog drug that inhibits HIV replication by interfering with the reverse transcriptase enzyme. The drug is FDA-approved for the treatment of HIV disease; current practice favors use in combinations. Adverse side effects may include nausea, peripheral neuropathy, oral ulcers and pancreatitis.

epidemic

an outbreak of a disease within a population. See also pandemic.

epidemiology

the study of the frequency, distribution and behavior of a disease within a population.

etiology

the cause of a disease; the study of causes of disease.

exclusion criteria

a list of criteria, any one of which excludes a potential subject from participation in a study.

external consistency

the consistency of a procedure between sets of data; very important for the quality of the outcome of any clinical trial.

good clinical practice

a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.

HAART

highly active antiretroviral therapy, a term for aggressive anti-HIV treatment. Also known as ART, ARV and HART.

hemophilia

a disorder that prevents normal blood clotting. Hemophilia is hereditary.

hepatic event

a potentially life-threatening effect of some ARV medications characterized by abrupt onset of flu-like symptoms (nausea, vomiting, myalgia, fatigue), abdominal pain, jaundice, or fever with our without skin rash. Greatest risk within first few weeks of therapy; can occur through 18 weeks.

hepatitis

inflammation of the liver. It may be caused by a viral, bacterial, or amoebic infection or may be part of an allergic response to medications. It can also occur as an autoimmune condition. See Hepatic Event.

herpes zoster

an inflammation of the skin caused by a Varicella-zoster virus (also causes chicken pox) characterized by collections of small blisters. Also known as 'shingles.'

hyperglycemia

raised levels of glucose in the blood typically seen in diabetes mellitus. Hyperglycemia may be seen with the use of protease inhibitors.

hyperlipidemea

raised levels of one or more class of lipoproteins in the blood. Lipid include cholesterol (LDL and HDL) and triglycerides. Use of protease inhibitors and Stavudine may be associated with an increase in total cholesterol and plasma triglycerides.

hypersensitivity reactions

an allergic disorder in which the body becomes hypersensitive to particular antigens, which provoke characteristic symptoms whenever they are subsequently encountered.

immune reactivation syndrome

a paradoxical worsening of pre-existing untreated opportunistic infections seen following the initiation of effective antiretroviral therapy. This reflects the immediate improvements in immune function that occur as levels of HIV RNA drop and the immunosuppressive effects of HIV infection are controlled.

immune reconstitution

restoration of the immune system.

immunomodulator (immune)

an agent or process capable of modifying or influencing the function of the immune system. Immune modulators include cytokines (e.g., IL-2, gamma interferon) and broad-acting agents. See also immunotherapy.

immunosuppression (immune suppression)

reduced function of the immune system; a state in which the immune system defenses have been suppressed, damaged or weakened.

inclusion criteria

the criteria that prospective subjects must meet to be eligible for participation in a study.

infectious

capable of being transmitted from one individual to another, for example through sexual contact.

informed consent

a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

injection drug user (IDU)

a person who uses a drug (e.g., heroin, cocaine) that is administered with a needle and syringe. The term intravenous drug user (IVDU) is also sometimes used. IDU is more general, and refers to injection methods other than intravenous administration.

integrase

a viral enzyme that enables the integration of viral genetic material into a host cell's DNA.

lipoaccumulation

one of two kinds of lipodystrophy; an increase of fat in localized areas of the body, particularly the abdomen, neck, upper back, and breasts. See lipoatrophy.

lipoatrophy

one of two kinds of lipodystrophy; characterized by fat loss in the arms, legs, buttocks, or face. See lipoaccumulation, wasting.

lipodystrophy

the umbrella term for pronounced loss or gain of body and blood fat that mostly afflicts HIV patients and people with rare inherited disorders.

long term non-progressor

an HIV-positive individual with low, steady levels of HIV in the blood and nearly normal CD4-cell count, potentially for more than 10-15 years.

log

short for logarithm, a unit of measurement indicating a 10-fold change (two-log change would indicate and 100-fold change, three-log change would indicate a 1,000-fold change, etc.)

lymphoma

cancer of the lymphatic system
maximal and durable suppression of the virus

near total and long-term suppression of the virus to undetectable levels in the blood

metabolic dysfunction

metabolism involves the breakdown of complex organic constituents of the body with liberation of energy, which is required for other processes. In HIV/AIDS metabolic dysfunction with the use of antiretroviral medications especially protease inhibitors relates to the disturbance of lipid and glucose metabolism.

monitoring

the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, good clinical practice, and the applicable regulatory requirements.

Motivational Interviewing (MI)

a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. Compared with non-directive counseling, it is more focused and goal-directed. Developed by William R. Miller, Ph.D., and Stephen Rollnick, Ph.D.

mycobacterium avium complex (mac)

a disease caused by Mycobacterium avium or Mycobacterium intracellular (sometimes referred to as Mycobacterium avium-intracellular or MAI), bacteria found in soil and water. In immunosuppressed persons, the bacteria can infect the lymph nodes, intestines, bone marrow, liver, spleen, spinal fluid, lungs and the gastrointestinal tract. MAC is the most common bacterial infection in persons with advanced AIDS (usually under 50-75 CD4 cells/mm3). Symptoms include diarrhea, wasting, fever, night sweats, fatigue and spleen enlargement. Clarithromycin is used as treatment and prophylaxis for MAC.

nevirapine (viramune, formerly birg-587)

a non-nucleoside reverse transcriptase inhibitor drug approved for the treatment of HIV disease. Nevirapine blocks HIV replication by binding to the reverse transcriptase enzyme. Side effects include rash and liver toxicity.

non-nucleoside reverse transcriptase inhibitor (NNRTI)

a drug (e.g., nevirapine, delavirdine) that inhibits the action of the HIV-1 reverse transcriptase enzyme, thus blocking HIV replication, yet works in a different way than nucleoside analog drugs, by binding with the RT enzyme.

opportunistic infection (OI)

an illness caused by a microorganism that usually does not cause disease in persons with healthy immune systems, but which may cause serious illness when the immune system is suppressed. Common OI in HIV positive people include Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) and cytomegalovirus (CMV) infection.

oral thrush

lesions in the oral cavity caused by a fungal infection (Candidiasis) commonly seen in HIV/AIDS.

pandemic (see epidemic)

a widespread disease outbreak affecting the population of an extensive area of the world. See also epidemic.

pathogenesis

the development of a particular disease, including the specific events involved, bodily tissues or systems affected, mechanisms of damage and timing of the course of disease.

pneumocystis carinii pneumonia (PCP)

a life-threatening type of pneumonia believed to be caused by a protozoan. PCP is a common infection that can cause severe illness in immunocompromised people (especially those with CD4 counts less than 200 cells/mm3); it remains a leading cause of death in people with AIDS. Symptoms include dry cough, fever, chest tightness and shortness of breath. Pneumocystis carinii can also infect other parts of the body. First-line treatment and primary prophylaxis is TMP-SMX (Bactrim, Septra); other treatments and prophylaxes include dapsone, pentamidine and atovaquone.

prophylaxis

a defense or protection. Several drugs are available to patients with suppressed immune systems to prevent certain opportunistic infections. For example, Bactrim is a prophylaxis against PCP. Using a condom is a prophylaxis against most sexually transmitted diseases.

protease

an enzyme that breaks down proteins and is used in cell replication. There are many kinds of protease, most of which are beneficial. One enzyme is specific to the HIV replication process.

protease inhibitor

a class of anti-HIV drug that prevents creation of an HIV-specific protease

randomization

the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

recruitment

process used by investigators to enroll appropriate subjects into a clinical study, i.e. those selected on the basis of the protocol's inclusion and exclusion criteria.

resistance

the ability of a microorganism to mutate or change its structure in such a way that it loses its sensitivity to a drug; a resistant organism can function and replicate despite the drug's presence. Contrast with susceptible. See also cross-resistance.

ribonucleic acid (RNA)

a single-stranded nucleic acid that encodes genetic information. RNA is made up of sequence of 4 chemical building blocks (nucleotides) -- adenine, cytosine, guanine and uracil. RNA is involved in the transcription of genetic information; the information encoded in DNA is translated into messenger RNA (mRNA), which controls the synthesis of new proteins. RNA takes the place of DNA in retroviruses such as HIV. The presence of HIV RNA in the plasma indicates that the virus is actively replicating.

seroconversion

the development of antibodies against a microorganism; the change in a person's antibody status from negative to positive.

shingles

See Herpes-zoster.

standard operating procedures

detailed, written instructions to achieve uniformity of the performance of a specific function.

Steven Johnson syndrome

a potentially life-threatening adverse effect of some ARV medications. Severe and serious allergic skin reactions with rash, fever, and blistering requiring hospitalization and immediate withdrawal of the offending medication.

subcutaneous fat

the fat found just under the skin that gives it a plump, padded look. Loss of this fat is associated with lipodystrophy.

viral load

a group of tests that measure the amount of HIV in the blood. The two most commonly used viral load methods are PCR and bDNA.

viral resistance

the degree to which the virus remains unaffected by antiretroviral medications. This occurs when the virus is exposed to sub-optimal levels of antiretroviral medications.

visceral fat

fat buried deep within your body's tissues; very difficult to get rid of.

vulnerable subjects

individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation. Examples include patients with incurable diseases, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, minors and those incapable of giving consent..

wasting

a term referring primarily to loss of muscle mass (as opposed to fat) and predates combo therapy; often confused with lipodystrophy.

wild type

strains of viruses found in nature as opposed to strains that have mutated within a laboratory setting or in the body over time.

window period

The time between primary infection and the appearance of antibodies against an organism (seroconversion).

Zidovudine

Also known as AZT or Retrovir is a type of antiretroviral drug called a nucleoside reverse transcriptase inhibitor (NRTI). This class of medicines blocks reverse transcriptase, an enzyme (cell protein that helps chemical reactions) that HIV needs to make more copies of itself. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.

Sources for this information include:

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, www.aidsinfo.nih.gov

Terms in the Glossary are from the AIDS Education General Information System (AEGIS): www.aegis.com unless otherwise indicated.

Adherence to ART in Adults: A Guide for Trainers; ACT - Applied Clinical Trials