Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Brief Summary: The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.


Options:
A: Note: Enrollment into this trial was halted 01/11/06.

Inclusion Criteria:

* HIV infection
* CD4 cell count greater than 350 cells/mm3 within 45 days of study entry
* Willing to start, change, or stop antiretroviral therapy
* Acceptable methods of contraception
* Good health at the time of study entry
* Available for the study for at least 6 months
* Able, in the clinician's opinion, to comply with the protocol

Exclusion Criteria:

* Currently participating in the MDR-HIV, NvR study, or another study which is not consistent with one of the treatment groups in this study. CPCRA FIRST participants may be screened for SMART after August 8, 2005 and can be randomized into SMART on or after September 19, 2005.
* Pregnant or breast-feeding
B: Inclusion Criteria:

1. Current patient at one of two SLR CCC clinics with a designated physician (had intake visit and enrolled into clinic)
2. Age 18 years or older;
3. Current or regular smoker (\>5 cigarettes per day);
4. Carbon Monoxide (CO) monitor reading of \>8 ppm;
5. Willingness to set a quit date;
6. Able to conduct activities in English;
7. Ability to provide informed consent;
8. Willingness to carry/use a cell phone; AND
9. Eligible to take varenicline as determined by the patient's primary care provider

Exclusion Criteria:

1. Unstable cardiovascular disease (e.g. uncontrolled blood pressure, unstable angina, or myocardial infarction in the past 4 weeks);
2. Current homicidal or suicidal ideation, history of suicidal ideation, or history of psychosis;
3. Has a serious or untreated psychiatric illness (major depression, bipolar or schizophrenia);
4. Severe renal impairment (defined as having a creatinine clearance \< 30mL/min);
5. Currently using smokeless tobacco;
6. Currently using FDA-approved smoking cessation medication or other smoking cessation treatment and or participating in another smoking cessation program;
7. Active drug use identified by a score of 6 or above on DAST-10 Drug Abuse Screening Test;
8. Alcohol dependence or risk drinking identified by a score of 5 or above for men and 4 or above for women on AUDIT-C Alcohol Use Disorders Identification Test
9. Pregnant or nursing; AND/OR
10. Has a cognitive impairment that would preclude giving consent.
C: Inclusion Criteria:

* HIV-infection
* current cigarette smoker
* high motivation to quit

Exclusion Criteria:

* Pregnancy
* breastfeeding
D: Inclusion Criteria:

* Be receiving care for HIV at one of the participating immunology clinics
* Be 18 years old or older
* Be current (past 7 days) cigarette smoker
* Speak English or Spanish

Exclusion Criteria:

* Are pregnant or nursing
* Have uncontrolled hypertension
* Use other forms of tobacco like cigars or chewing tobacco or are using anything else to help with quitting smoking
* Are allergic to the nicotine patch or have a skin condition like eczema or psoriasis that makes them unable to use the patch

Answer: A