NAPWA

The US Food and Drug Administration (FDAThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. The Australian equivalent is the Therapeutic Goods Administration (TGA[Therapeutic Goods Administration] The federal government body that approves drugs and treatments before they can be prescribed.).) recently issued a warning to people taking the highest approved dose of simvastatin, a common cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liverA large organ, located in the upper right abdomen, which assists in digestion by metabolising carbohydrates, fats and proteins, stores vitamins and minerals, produces amino acids, bile and cholesterol, and removes toxins from the blood., and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effectAn unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. of some anti-HIV medications.-lowering medication, that they have an increased risk of muscle injury compared to people taking lower doses of the drug. read more »

Adrian Ogier gives a round up of treatments news from the Vienna Conference read more »

An Australian expert was heard to say recently that AIDS has been cured and HIV should now be thought of as a disease of inflammation. Neil McKellar-Stewart tends to agree.

More and more these days, health issues apart from HIV are taking centre stage in our lives. On top of the list are lifestyle changes that we are being encouraged to make to reduce our risk of contracting other illnesses. read more »

The XVIII International AIDS Conference has officially started with an opening session focusing heavily on the need for action on human rights and a call by an Australian researcher for greater focus on the prospect of a cure for HIV. read more »

Doctor Louise answers readers' questions. In this issue she discusses blood tests and gastric reflux. read more »

Information about the START trial, which is seeking to establish the best time to start HIV treatment. read more »

NAPWA recently contributed to the Clinical TrialA clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase IA clinical trial designed to establish whether an experimental drug is safe for humans to take. Phase I studies determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and look for early evidence of effectiveness; these studies may include either people with HIV, HIV-negative volunteers, or both tests a new drug or treatment in a small group; Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. expands the study to a larger group of people; Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. expands the study to an even larger group of people; and Phase IVPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. takes place after the drug or treatment has been licensed and marketed. Action Group. NAPWA has been closely engaged in clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trials involving PLHIVPerson (or people) Living with HIV. This term is now preferred over the older PLWHA. throughout its history. read more »

The Conference on Retroviruses and Opportunistic Infections (CROI) has just happened in San Francisco. This meeting is held annually and focuses on the very latest in basic science and clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. research. Jo Watson was there and gives us an overview. read more »

Maintaining a CD4 cell count above 500 helps protect you from a range of AIDS-defining and non-AIDS-defining cancers, French investigators report.

Researchers followed over 50,000 positive people between 1998 and 2006 and found that the seven* most common cancers were found least in those whose counts stayed consistently above 500. read more »