
acquired immunodeficiency syndrome

A late stage of HIV infection, characterized by a deterioration of the immune system that leaves the body vulnerable to a range of infections and cancers.

Active Pharmaceutical Ingredient

Any substance or mixture of substances intended to cause positive effects in the diagnosis, improvement, treatment or prevention of a disease. In a medical product, the chemical or mixture of chemicals that demonstrate(s) biological activity.

adverse event

An unwanted effect, either measured in or reported by participants in a clinical trial. This term is used whether or not the effect is believed to have been caused by the product being studied.

adverse reaction

An unwanted effect, or side effect, detected in clinical trial participants and attributed to the product being studied in that trial. Also applies to marketed and approved products.


acquired immunodeficiency syndrome


Proteins found in the blood and other bodily fluids that are used by the immune system to identify and counteract foreign objects, such as bacteria and viruses.


A molecule recognized by the immune system.  This includes molecules specifically recognized by antibodies or by T cells. Molecules known as foreign antigens are associated with toxins, bacteria, viruses, foreign blood cells and cells from transplanted organs. The unrecognized shape of these foreign molecules triggers the immune system to produce antibodies or to activate T cells, thereby fighting an infection.


A drug that attacks a retrovirus, like HIV, by inhibiting binding to and entering into a human cell or by preventing the virus from producing more copies of itself once inside the cell. ARVs reduce the spread of virally-infected cells throughout the body.


active pharmaceutical ingredient



Attachment Inhibitor

Class of anti-HIV (ARV) drugs that prevents the virus from attaching to a healthy host cell, thereby preventing cell infection.

B cell

Also known as a B lymphocyte, B cells are infection-fighting white blood cells that develop in the bone marrow and spleen. B cells produce antibodies, which are used by the immune system to identify and counteract foreign objects like bacteria and viruses. HIV may damage the B cells’ ability to do their job.

blinded study

A clinical trial in which participants are unaware of who is included in an experimental arm (given an active drug) or control arm (given the placebo) of the study. (See also double-blind study.)

CCR5 blocker (microbicide and ARV class)

A microbicide in the entry inhibitor class prevents the virus from attaching to the host cell (lymphocyte or macrophage) by blocking the ability of HIV to interact with the CCR5 receptors on the cell surface>

CCR5 receptor

Receptors on the surface of the host cells to which HIV attaches. CCR5 is the receptor on lymphocytes and macrophages and is thought to be more important in sexual transmission of HIV than CXCR4.

CD4 receptor

A protein on the outside of infection-fighting white blood cells that allows HIV to bind to and enter the cells.


In the HIV life cycle, copy DNA, or complementary DNA, is made after the virus has entered the cell and is beginning the process of replicating itself to take over the healthy cell. cDNA is formed as a copy of the HIV’s genetic material, which is single-stranded ribonucleic acid, or RNA.

Civil Society Organization

Civil society organizations, or CSOs, refer to a wide range of citizens’ associations that provide benefits, services or political influence to specific groups within society. CSOs include business forums, faith-based associations, labor unions, local community groups, nongovernmental organizations (NGOs) and think tanks.


A genre or grouping of drug products that all work in a similar way. Often we refer to a class of microbicide, which indicates the way that it prevents HIV infection.

clinical trial

Research studies that include human volunteers. Clinical trials answer specific questions about the safety, efficacy and medical effects of a specific prevention, treatment or intervention. Carefully conducted clinical trials are required to test and seek licensure for effective disease treatments and preventions. There are typically three phases of clinical trials before the filing with regulatory authorities, sometimes followed by ongoing, post-approval trials. (See also Phase I, Phase II, Phase III, and Phase IV)

Clinical Trial Material Facility

IPM’s facility responsible for producing the products used in clinical trials, including the active drug and the placebo. This refers to facilities owned by IPM or to other locations/research centers owned and operated by another manufacturer.

cluster of differentiation

The abbreviation for “cluster of differentiation,” referring to a set of cell-surface molecules that are used to identify the types and stages of maturity of immune cells, for example, CD4+ T cells.

coitally dependent

An intervention that must be applied or used near the time of sexual intercourse.


Critical Quality Attribute

Critical Quality Attribute

A property of a drug product that should be within an appropriate limit, range, or distribution to ensure the desired quality of a product.

cross resistance

Occurs when resistance to one drug results in resistance to similar drugs.


civil society organization


Clinical Trial Manufacturing Facility

CXCR4 receptor


daily monitored adherence


Data and Safety Monitoring Board


Dendritic cell


Design of Experiment





design of experiment

double-blind study


drug product



Drug Safety Monitoring Board


A product’s ability to achieve a desired effect. In the case of microbicides, efficacy refers to the ability of the product to reduce the risk of becoming infected with HIV and perhaps other pathogens.

entry inhibitor

A class or type of anti-HIV drugs designed to disrupt the ability of HIV to enter a host cell through the cell's surface.


A disease that has spread rapidly through a segment of the human population in a given geographic area.


The study of the frequency and distribution of disease in human populations.


A necessary component of a drug product other than the active ingredient. These components may include substances to make the product stable over time or resistant to heat and humidity. Excipients also are required to create the physical nature of the product. These could be fillers to make up a solid oral tablet or gel-like substances in the case of some microbicides. The excipient in a drug product is like the chocolate in a chocolate cake. To make the cake itself, there are a number of active ingredients, like flour and eggs, but without the chocolate, the chocolate cake is not a finished product.


The form in which a drug or product is tested and later supplied to consumers.  Common formulations are tablets, soft-gel capsules, oral liquids, injected liquids, creams and dermal patches. Microbicides can be in created in the form of rings, gels, films, tablets or others yet to be developed.


This stage in the HIV life cycle occurs after the attachment stage. The viral envelope, which is like the shell or skin of the virus, fuses with the host cell’s membrane, or skin.  As the cell and the virus fuse to become one entity, the contents of the virus are released into the cell.


Good Clinical Practice




Good Manufactoring Practice

Good Clinical Practice


Good Manufacturing Practice







Highly Active Antiretroviral Therapy

half life

Amount of time needed for half of the amount of drug administered to be eliminated from the body.

Herpes Simplex Virus 1

A virus that causes cold sores or fever blisters on the mouth or around the eyes and that can be transmitted to the genital region. The virus can become inactive (latent), and symptoms disappear. Stress, trauma, other infections or a suppressed immune system can reactivate the virus in a body, causing the symptoms to return.

Herpes Simplex Virus 2

A virus that causes painful sores around the anus or genitals. The virus can become inactive (latent), and symptoms then disappear until it becomes active again in the body. HSV-2 may be transmitted either sexually or from an infected mother to her infant during birth.

Highly Active Antiretroviral Therapy

The name given to treatment regimens that aggressively inhibit the spread of HIV in the body. The usual HAART regimen combines three or more anti-HIV drugs from at least two different classes.


Histology is the study of microscopic anatomy of cells and tissues in animals and plants. A histological study of cells or tissues is often used to help diagnose a disease or illness.


Human Immunodeficiency Virus. The virus that causes AIDS. Human immunodeficiency virus, or HIV, is in the retrovirus family of viruses. There are two types of HIV — HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world, whereas HIV-2 is found primarily in West Africa.


Herpes Simplex Virus 1


Herpes Simplex Virus 2

human immunodeficiency virus


in vitro

Research conducted in the laboratory with cultured, living cells or purified cellular components, i.e. in a test tube.

in vivo

Research conducted in living organisms (humans or animal models). Also see preclinical research.


The number of new cases of a disease over a period of time (e.g., the annual number of new cases of HIV in a country). Incidence is often expressed as a percentage of a population. (Contrast with prevalence)


investigational new drug

informed consent

An ongoing process of counseling and communication through which potential clinical trial participants learn about the risks and benefits of participating in the trial so that they can decide whether or not to participate voluntarily.


The last stage in the HIV life cycle when viral cDNA, which is created based on viral RNA, enters the host cell nucleus and becomes incorporated into the host cell’s genetic material, permanently “infecting” that cell.

Investigational New Drug Application

An application filed by a sponsor with the FDA requesting approval to conduct clinical trials. The IND includes detailed descriptions of all trial phases, protocols, Institutional Review Board (IRB) members, and investigators.


Types of white blood cell in the immune system. Many of these cells are involved in protecting the body from infection, such as B cells, T cells and natural killer (NK) cells. T cells, or T lymphocytes, are directly involved in the HIV infection cycle.


Derived from the Greek words for “big” and “eat,” macrophages are a type of disease-fighting white blood cell that engulfs and then destroys foreign invaders, like viruses, and calls other immune system cells to action.

mechanism of action

The way in which a drug or product works. In the case of a microbicide, it is the way in which the active ARV component protects healthy cells from HIV infection.


A natural or man-made substance that kills microbes, most often bacteria or viruses. Researchers are developing microbicides to reduce the transmission of HIV during sexual intercourse.

next-generation microbicide



nongovernmental organization


non-nucleoside reverse transcriptase inhibitor

non-nucleoside reverse transcriptase inhibitor


noncoitally dependent


nongovernmental organization


nucleotide reverse transcriptase inhibitors





product development partnership







Phase I


Phase II


Phase IIb


Phase III


Phase IV


pilot scale batch










preclinical research




product development partnership





quality assurance

Quality Assurance

The externally planned actions that ensure that a product being manufactured or a clinical trial being performed meets the requirements set forth by the  Good Clinical Practice (GCP) guidelines and any regulatory requirement(s).


The process of assigning trial participants to either a treatment group where they receive the drug product, or a control group where they receive the placebo. A methodology is employed that applies an element of chance to determine the assignments. This method reduces bias.

randomized trial

A study in which the participants are assigned by chance to separate groups that compare different treatments. Neither the researchers nor the participants can choose group assignments. Using chance to assign people to groups means the treatments they receive can be compared objectively.


A molecule on the surface of a cell that serves as a recognition or binding site for antigens, antibodies, hormones or other cellular or immunologic components. When chemical messengers bind to receptors, various cellular functions are activated or inhibited. Viruses enter host cells by interacting with receptors on the cell surface, and many drugs exert their effects by binding to receptors, thereby altering cellular function.

regulatory body

The group or groups responsible for making sure that all laws regulating research, testing, and other stages of drug development and approval are upheld during clinical trials and research and development for a new product. Regulators also establish what will be required for each new product to be approved for use. The Food and Drug Administration (FDA) is the key regulatory body for new drug products in the United States.

replication stage

The stage in the HIV life cycle when the genetic material of the virus is copied using the reverse transcriptase enzyme. This stage occurs after fusion. Once the virus has permanently integrated into the host cell, the virus can then duplicated using the cell’s own biological processes.


Some microorganisms, including viruses like HIV, adapt so they can survive and multiply in the presence of drugs that would normally weaken or kill them. A drug-resistant HIV strain can multiply in the presence of one or more ARV drugs because of its genetic make-up.


HIV and other viruses that carry their genetic material in the form of single-stranded RNA rather than the double-stranded DNA .  Retroviruses also have the enzyme reverse transcriptase that can copy RNA into cDNA, leading to infection of the host cell.

reverse transcriptase

An HIV enzyme used by the virus to copy its RNA into cDNA, to allow for its incorporation into the host cell DNA.

reverse transcriptase inhibitor

A class of microbicides that works by preventing the action of the reverse transcriptase enzyme.

reverse transcription

The process during viral replication when the HIV enzyme reverse transcriptase converts single-stranded viral RNA into double-stranded DNA so that the HIV genetic material can be integrated into the human cell. See also viral replication.

ribonucleic acid

Also called RNA, ribonuclei acid is a type of macromolecule that stores and transfers genetic information. Although DNA is the primary genetic material of mammalian cells, RNA is the genetic material for some viruses, including HIV. 


ribonucleic acid


A product’s safety is measured by the magnitude of its measured harmful effects when it is administered. A safe product is one that has limited harmful effects at the dose to be used in the target population.


Transition from small-scale to production of larger and larger batches of material, eventually leading to processes that support manufacturing of industrial quantities of drug product.


A term used to indicate that an individual has become infected with HIV. Biologically, it refers to the development of antibodies to HIV, which is measured by clinicians as a biomarker of HIV infection. When people develop antibodies to HIV, they “seroconvert” from antibody-negative to antibody-positive (from HIV-negative to HIV-positive).

shelf life

Also referred to as expiration dating period, the shelf life is the time period during which a drug product is expected to remain effective, provided that it is stored under the conditions defined on the container label.


small inhibitory RNA

Site Initiation Visit

A visit held prior to participant enrollment at a research center. The purpose is to acquaint all research center personnel with the relevant aspects of the trial prior to any participant enrollment. Components of this discussion include the clinical trial protocol, case report forms, missed visits, Institutional Review Board (IRB) practices,  Institutional Ethics Committee (IEC) reporting requirements, adverse event reporting, etc.


site initiation visit

small inhibitory RNA

Small inhibitory RNA, or siRNA, is artificially created RNA [link to “RNA” entry] that prevents naturally occurring RNA from translating into protein. siRNA can be used as an effective tool to study biological processes in the laboratory. Some researchers are exploring the potential to use siRNA for disease treatment.

stability studies

These are long-term, intermediate and accelerated  studies used to establish or confirm the shelf life of a drug product or to make sure the drug product is still active and potent under a number of environmental conditions.

standard of care

A basic process that a health-care provider or clinical trial investigator should follow for a certain type of patient or illness.

T cell

Small, disease-fighting white blood cells (also known as T lymphocytes) involved in immune defense. T cells include CD4 cells and CD8 cells, which are both critical components of the body’s immune system. T cells are the main target of HIV in the blood, and they act as the host that the virus needs in order to replicate. Because it targets and “hijacks” immune cells, HIV is particularly destructive on the immune system.


The substance or mixture of substances in which the active ingredient in a drug product is prepared. Vehicles are typically liquids in which the active ingredient can be dissolved effectively into a homogeneous solution.  Examples of vehicles are phosphate-buffered saline (PBS), sucrose-phosphate-glutamate (SPG), normal saline and hydroxyethylcellulose (HEC). HEC is a commonly used vehicle for microbicide gels.

viral attachment

The first stage in the HIV life cycle, in which the virus attaches to the host cell.

viral replication

The stages of the HIV life cycle beginning when the genetic material of the virus is copied into DNA using the reverse transcriptase enzyme and ending with the replicated virus being released from the human cell. In the viral replication process, HIV first integrates its genetic material permanently into the host cell, then duplicates itself using the cell's own biological process.


A mature infectious virus particle existing outside a cell.