Introduction
The ACTU (AIDS Clinical Trials Unit) at the Partners AIDS Research Center is one of 35 medical centers designated by the National Institutes of Health (NIH) to investigate promising new treatments for adults who are infected with the human immunodeficiency virus (HIV). The information that follows is designed to provide you with a better understanding of the ACTU and also to explain the process and requirements for becoming a participant in our clinical trials program.

Purpose of the ACTU
The primary mission of the ACTU is to evaluate the safety and effectiveness of medications against HIV. The information learned here may affect the health of millions of people who are infected with HIV. This information is useful only when it is reliable, which means it must be gathered and analyzed in a scientific manner with appropriate controls and checks. The Harvard/BMC ACTU is involved in many different protocols for both inpatients and outpatients. A protocol is simply a scientific term for the outline of a research study. It is important that you know that the ACTU must follow the protocols exactly -- and this requires that we develop a close working relationship and stay in contact.

Screening
Following a preliminary telephone screening, you will be asked to visit the ACTU. To ensure the best access and convenience for patients, we offer two different sites at Partners. One unit is located on the 5th Floor of the Cox building in the Massachusetts General Hospital, and another is located at the Brigham and Women’s Hospital on the 4th floor of Building A. We may require that you obtain copies of your medical records including information on your HIV diagnosis and medication history, before we are able to set up a screening visit. During the screening visit, we will ask you about your past medical history, review your records and confirm that you are HIV antibody positive in order to determine if you are eligible for any active protocol. A small amount of blood will be drawn during this visit. The blood will be analyzed to determine if you meet the study's laboratory criteria for entry. Some protocols may require more than one blood drawing. Therefore, you may be asked to return to the clinic at a later date for more evaluations. Most screening laboratory results are available within one week. Your study nurse (assigned at your first screening visit) will call and explain the lab results to you. If you meet the study criteria, you will be asked to return to the clinic and participate in the study.

For some of our studies, you will have a complete physical examination by an ACTU physician. These physicians are all on the staff of the MGH and/or BWH, and have extensive experience in treating HIV infection. We may request a letter of referral from your current doctor and possibly other medical records of past medical care or hospitalizations.

Consent forms
You will be asked to sign a consent form during your screening for the study. The consent form summarizes the purpose of the study and explains all the potential risks and benefits for each study. It is important that you understand the consent form; you will have a chance to ask questions before signing. Look upon the consent form as a pact between the ACTU and you.

Enrollment
Enrollment occurs after the screening laboratory tests or other evaluations required by the study are completed. The entry visit usually takes about one hour. At this visit, you will receive your study medication and instructions on your dosing regimen. You may also have additional laboratory tests done.

Follow-up visits
The number and frequency of follow-up visits to the ACTU varies from protocol to protocol. The length of each visit also varies. Some are very brief with only a blood drawing required; others can last more than an hour if a complete physical is required. At each visit, we will want to know how you have been since we last saw you. We will ask you about any symptoms of illness that may have occurred since your previous visit. Please remember to bring back your bottles of study medication whether or not they are empty. We will exchange them for new bottles. It is very important the you tell your nurse or doctor about all your symptoms, whether they seem to be related to the drug, the AIDS virus or other medications including vitamins and herbal preparations that you have taken since your last clinic appointment. Please call your study nurse and keep her informed. The trials depend on teamwork between the patient and the study staff. Your health and well-being are extremely important to us, so please call and let us know how you are doing.

A blood sample is drawn and analyzed at most of the follow-up visits in order to monitor the effect of the study medications on your body. Periodically, a physician will also take another medical history and perform a complete physical examination.

Test results
We will keep you informed of the results of your laboratory tests at follow-up visits. With your permission, your private physician will also be informed of your lab results. Alternatively, if you so choose, all of these records can be kept confidential.

Costs
The clinic visits, evaluations and all the laboratory tests required by the study are free. Study medications are also frequently free. However, you (or your insurance provider) will still be responsible for any costs associated with your ongoing, routine medical care.

Blinded and Controlled Studies
In order to fairly judge the benefits and side effects of the drug without bias, some of the protocols will be blinded (i.e., you will not know during the trial which study medication you are receiving). It has been documented that assessment of a research drug can best be evaluated in blinded and randomized clinical trials. Studies sometimes use a "placebo" to help blind the study. A placebo is an inactive substance that is given to some patients instead of the actual drug. Also, many studies are "randomized;" this means patients may be assigned by chance (like tossing a coin) to being in one or another treatment arm of the study.

Safeguards
To minimize or avoid risks and hazards associated with this study, the clinical care team will:

	Provide drugs under close supervision and explain in detail the dosing regimen (when and how to take the medications)
	Draw blood to monitor your lab values at each visit for potential toxicities
	Record your symptoms and perform appropriate physical exams to also monitor for side effects or toxicities.

Risks
There may be risks associated with participation in each study. The risks are usually due to the potential side effects (toxicities) caused by the study medications. We will follow you as closely as possible to minimize the chance that you will experience a side effect. However, some of the side effects are unknown and are discovered during the conduct of these studies.

Benefits
Your participation in an HIV/AIDS research program will provide many benefits, both to you and others. You will be followed closely by our health care team for any change in your medical condition. Most studies provide laboratory results (e.g. Viral Load, CD4) directly to you and to your primary care doctor. An unbiased review panel composed of research physicians will be closely monitoring the study for both effectiveness and toxicity. If there is evidence that one treatment arm is better, then the study is halted and all patients are switched to this treatment arm. If there is a clear indication that a drug regimen is ineffective or too toxic, then the study will be halted.

Illness/hospitalization
If you should become ill and require health care, please contact your primary care physician. We also need to be informed if you become sick and/or require hospitalization. A member of the ACTU staff must be notified of any significant changes in your health status and the development of symptoms because this information may be relevant for the research study. If you do not have a personal physician, the ACTU staff will help you in getting a primary care doctor who is knowledgeable about AIDS and HIV infection. Hospitalization costs are not covered by the ACTU unless hospitalization is required by the protocol for the study. Therefore, you or your health care provider is responsible for any medical costs incurred due to illness.

Adherence
It is absolutely essential patients adhere with the drug dosing regimen prescribed for the study for two reasons: First, resistance to the antiretroviral medications is likely to develop if you do not take all of your prescribed medications. Second, when data are analyzed at the end of the study, a patient's records may be excluded from the evaluation if there has not been complete adherence. If you feel you cannot tolerate a medication, please tell your study nurse so he/she and the physician can assist you by adjusting the dose or the timing of the medication. You may also increase your tolerance by eating or drinking certain foods or liquids. Serious compliance problems may result in a patient being discontinued from the study. Missed appointments
If you are unable to make your next scheduled appointment, please let us know as soon as possible. The amount of medicine that your received at you last appointment will be enough to last until your next visit. Therefore, if you must change your appointment, it's best to reschedule right away to ensure that you have an adequate supply of medication.

Confidentiality
The ACTU clinical care team is sensitive to the privacy concerns of participants. We recognize the importance of confidentiality and have made major efforts to insure that your records are protected. The data collection records for our studies will not have your name on them; you are identified by a 7-digit code, called your Patient Identifier or PID, which is assigned to you on the day of your enrollment. The identifier -- not your name -- appears on your study records. The patient roster, which connects names to PIDs, is kept in a locked cabinet.

Off treatment follow-up
If you need to discontinue a study drug while the study is ongoing, the ACTU staff may still need to contact you. It is vital to the analysis of the study to be able to follow every study participant. You can help the staff by informing them when your address or phone number has changed, even if you are no longer taking study medications.

Patient withdrawal
Study participation is always voluntary. You may withdraw from the study at any time for any reason without jeopardizing your future medical care at the Massachusetts General Hospital or Brigham and Women’s Hospital. Transportation/parking
The MGH ACTU is located on the 5th floor of the Cox building.

MGH is located next to the MBTA Charles/MGH MBTA station. If you drive to the MGH complex, you can park at either of two garages. Parking coupons are available by request. Reimbursement is available for taxicab or bus or train fares if you present your receipt to your study nurse.

The BWH ACTU located on the 4th floor of Building A, 75 Francis Street, and can be reached on the MBTA green line, Huntington Ave. trolley, by the Brigham Circle stop. There is also parking available at the BWH parking garage.

History

Interventional and Observational Clinical Trials

A Patient's Guide to the AIDS Clinical Trials Unit (ACTU)

Acute HIV Research Group

HIV Elite Controller Study