CLINICAL TRIAL STUDIES

CLINICAL TRIAL STUDIES
by Daddy Dab, Jacksonville, FL

WHAT IS AN HIV/AIDS CLINICAL TRIAL

HIV/AIDS CLINICAL TRIALS ARE RESEARCH STUDIES IN WHICH NEW THERAPIES AND PREVENTION STRATEGIES FOR HIV INFECTION AND AIDS ARE TESTED IN HUMANS. THESE STUDIES ARE CONDUCTED BY PHYSICIANS AND OTHER HEALTH CARE PROFESSIONALS AND CAN HELP DETERMINE THE USEFULNESS OF EXPERIMENTAL DRUGS AND VACCINES IN TREATING OR PREVENTING HIV INFECTION.

NEW THERAPIES ARE TESTED IN HUMANS ONLY AFTER LABORATORY AND ANIMAL STUDIES SHOW PROMISING RESULTS. IN PHASE I CLINICAL TRIAL STUDIES, THE EXPERIMENTAL THERAPIES ARE GIVEN TO SMALL NUMBERS OF PEOPLE TO HELP DETERMINE SAFE DOSES. LARGER GROUPS OF PATIENTS MAY THEN RECEIVE THE THERAPIES IN PHASE II TRIALS TO HELP MEASURE SIDE EFFECTS AND PRELIMINARY EFFECTIVENESS. THE TREATMENTS MAY THEN BE USED IN TRIAL III STUDIES TO COMPARE THE NEW TREATMENT TO ONES ALREADY IN USE OR TO HELP ESTIMATE OTHER EFFECTS OF THE DRUG.

WHAT IS CLINICAL TRIAL PROTOCOL?

A CLINICAL TRIAL PROTOCOL IS A DETAILED PLAN OF HOW THE TRIAL WILL BE CONDUCTED. POTENTIAL CLINICAL TRIAL PARTICIPANTS LEARN DETAILS ABOUT THE CLINICAL TRIAL PROTOCOL IN A PROCESS CALLED INFORMED CONSENT.

INFORMED CONSENT IS THE PROCESS OF LEARNING KEY FACTS ABOUT A CLINICAL TRIAL STUDY BEFORE DECIDING WHETHER OR NOT TO PARTICIPATE. TO HELP SOMEONE TO DECIDE WHETHER OR NOT TO PARTICIPATE, STUDY STAFF EXPLAIN THE DETAILS OF THE TRIAL. THEN THE RESEARCH TEAM PROVIDES AN INFORMED CONSENT DOCUMENT THAT INCLUDES DETAILS ABOUT THE STUDY, SUCH AS ITS PURPOSE, DURATION, REQUIRED PROCEDURES, AND KEY CONTACTS. THE PARTICIPANT THAT DECIDES WHETHER OR NOT TO SIGN THE FORM. INFORMED CONSENT IS AN ONGOING PROCESS AND THE PARTICIPANT MAY WITHDRAW FROM THE TRIAL AT ANY TIME.

BENEFITS OF PARTICIPATING IN AN HIV/AIDS TRIAL STUDY:

* PARTICIPANTS MAY GAIN ACCESS TO NEW TREATMENTS NOT YET AVAILABLE TO THE PUBLIC

* PARTICIPANTS MAY RECEIVE EXPERT MEDICAL CARE AT LEADING HEALTH CARE FACILITIES.

* PARTICIPANTS HAVE A CHANCE TO HELP OTHERS BY CONTRIBUTING TO MEDICAL RESEARCH

* EXPERIMENTAL DRUGS ARE USUALLY PROVIDED FREE OF CHARGE

* MOST STUDIES PAY FOR AIRFARE AND HOTEL AFTER YOU ACCEPTANCE INTO THE TRIAL STUDY.

RISKS OF PARTICIPATING IN AN HIV/AIDS CLINICAL TRIAL STUDY:

* EXPERIMENTAL DRUGS MAY NOT HAVE ANY BENEFITS OR MAY EVEN BE HARMFUL

* NEW DRUGS MAY HAVE UNANTICIPATED SIDE EFFECTS AND ON VERY RARE OCCASIONS EVEN DEATH.

* PARTICIPATION MAY REQUIRE A LOT OF THE PARTICIPANT'S TIME AND FREQUENT TRIPS TO THE STUDY SITE.

QUESTIONS YOU SHOULD ASK YOURSELF:

* WHAT IS THE PURPOSE OF THE STUDY?

* WHAT ARE THE DRUG'S SIDE EFFECTS?

* HOW LONG DOES THE STUDY LAST AND HOW OFTEN MUST I BE THERE?

* WHAT OTHER OPTION DO I HAVE?

* WILL I HAVE TO STAY IN THE HOSPITAL OR OUTPATIENT TREATMENT?

* WHO WILL PROVIDE MY MEDICAL CARE AFTER THE STUDY IS OVER?

* WHAT OTHER MEDICATIONS CAN I TAKE WHILE PARTICIPATING IN THE STUDY?

* WHAT TREATMENTS SHOULD I AVOID WHILE IN THE TRIAL?

* WHO WILL PAY THE COSTS OF THE STUDY?

* HOW IS MY CONFIDENTIALITY PROTECTED?

TO FIND OUT MORE ABOUT CLINICAL TRIAL STUDIES AIDSINFO PROVIDES FREE, UP-TO-DATE INFORMATION ON CLINICAL TRIAL STUDIES FOR HIV/AIDS. YOU CAN SPEAK WITH EXPERIENCED HEALTH INFORMATION SPECIALISTS WHO CAN ANSWER QUESTIONS CONCERNING A CLINICAL TRIAL'S PURPOSE, LENGTH, LOCATION, ELIGIBILITY REQUIREMENTS, NAMES AND TELEPHONE NUMBERS OF THE CONTACT PERSON FOR THE STUDY AND MORE. THEY ALSO HAVE BILINGUAL SPECIALISTS FOR OTHER THAN ENGLISH SPEAKING CLIENTS.

1-800-HIV-0440 (1-800-448-0440) EMAIL: ContactUs@AIDSinfo.nih.gov Website: http://aidsinfo.nih.gov

In Jacksonville, FL; you can contact the BCC (Boulevard Clinic) and Shands Hospital about local clinical trial studies.

I personally have been involved in clinical trial studies at NIH in Bethesda, MD; CDC in Atlanta, GA; UCLA in Los Angeles, UCSF in San Francisco and Shands Hospital in Jacksonville, FL. The staffs tend to be not only professional but empathetic and compassionate people. Clinical trial studies can provide health care for those currently not insured or on ADAP waiting lists as long as they meet study criteria. Unfortunately, most lost term AIDS patients do not qualify for most studies due to the studies requirements.