Cari volunteers with the Hawaii AIDS Clinical Trials Unit at the Queen's Medical Center. The following is a description of the research program she is involved in.
Consent to be a Research Subject
I. Investigator in Hawaii
Cecilia M. Shikuma, M.D.
II. Title
ACTG 343 (version 1.0) "A Prospective Randomized Double-Blind Trial of Three Maintenance Regimens for HIV Infected Subjects Receiving Induction Therapy with Zidovudine, Lamivudine and Indinavir."
III. Informed Consent
I am being asked to take part in this research study because I am infected with HIV (the virus which causes AIDS), and have greater than 200 CD4 cells (T-cell, type of white blood cell) per milliliter of blood.
Before I decide whether or not to take part in this study, I must understand the purpose, how it may help me, any risks to me, and what I have to do. This process is called informed consent. The consent form gives me information about the study that wi ll be discussed with me. Once I understand the study, and if I agree to take part, I will be asked to sign this consent form. I will be given a copy to keep.
Before I learn about the study, it is important that I know the following:
--Taking part is of my own free will.
--I may decide not to take part in the study or stop being in the study at any time without it making any difference to my care now or in the future, or to any benefits that I am allowed.
--If the study is changed in any way which could make a difference to me, I will be told about the changes and may be asked to sign a new informed consent.
IV. Expected Length of Time in Study
This study will last for about 3 years.
V. Purpose of the Study
The main purpose of this study is to find out how useful certain drug treatments are at keeping the amount of HIV in the blood low. It is also to see if aggressive anti-HIV treatment can be stopped after being used a long time. The drugs that will be u sed in this study are indinavir (IDV), zidovudine (AZT), and lamivudine (3TC). People who cannot take AZT will take stavudine (d4T). All of these drugs are available by prescription.
VI. Procedures
--I must be at least 18 years old.
--I must have 200 or more CD4 cells (type of white blood cell) within 90 days of starting study drug.
--I must have a certain amount of HIV in my blood.
--I must not be pregnant or breast-feeding a baby.
--I must not have taken certain anti-HIV drugs.
Before I start the study, I must tell the research doctor or nurse before taking any non-study drugs or entering into other research studies. Some of my blood and/or tissue taken as part of this study will be stored (my identify will be protected) and may be used for AIDS related research in the future. This research will need to be approved by the AIDS Clinical Trials Group (ACTG).
Brief study summary:
During the first 6 month of the study (Part I), all patients will get the same 3 drugs taken together: indinavir (IDV) + zidovudine (AZT) + lamivudine (3TC). All patients will be taking the real drugs. After the first 6 months, patients will be random ized (which is like the flip of a coin) to one of 3 different treatment groups for the next 12 months (Part II). The three treatments in Part II are:
-- Group I: AZT 30Omg 2 times a day + 3TC 150mg 2 times a day + IDV 8OOmg 3 times a day.
-- Group II: AZT 30Omg 2 times a day + 3TC 150mg 2 times a day +IDV placebo* 3 times a day.
-- Group III: AZT placebos 2 times a day + 3TC placebos 2 times a day + IDV 800mg 3 times a day.
*placebo: fake pill containing no active drug; pill that looks the same as the real drug.
Part II of the study is double-blinded which means that neither my doctors, research nurses, nor I will know which are the active drugs and which are the placebos.
In Part III of the study, 120 patients (40 from each treatment group) who have no signs of HIV infection will be randomly (by chance) chosen to be taken off from treatment after being treated in Part II for 12 months. There will be 60 patients (20 fror n each treatment group) taken off from treatment after being treated in Part II for 18 months and another 60 patients (20 from each treatment group) taken off from treatment after being treated in Part II for 24 months. The rest of the patients will keep taking their Part II drugs for the rest of the study.
Detailed study procedures:
Screening:
I will be seen in the clinic 2 times before starting study drug. At the first screening visit, I will be asked about my medical history, have a physical exam, and blood tests done. About 3-4 tablespoons of blood will be taken from a vein in my arm. I f I am being tested for HIV, I may need to sign another consent form. If I am a woman and can still have children, I will have a pregnancy test done which will mean having an extra teaspoon of blood taken. At the second screening visit, I will have about 2 3 tablespoons of blood taken and will need to give a urine sample. The urine will be tested to see if there is blood in it.