START (STRATEGIC TIMING OF ANTIRETROVIRAL TREATMENT)
Study Status
Open to Enrollment
Study Description
When is the best time to start taking HIV medications?
The START study (Strategic Timing of AntiRetroviral Treatment) is recruiting HIV-positive men and women whose T-cell count (also called “CD4 count”) is greater than 500 and who have never taken HIV medications. The purpose of the study is to determine when is the best time to start taking HIV medications.
Current medical guidelines suggest that HIV-positive people whose T-cells drop below 350, or who have symptoms of AIDS, should start taking HIV medications. However, many medical experts believe that HIV treatment should be started even when the T-cells are above 350. Recent research suggests that even at higher T-cell counts, HIV-positive people who aren’t taking HIV medications may develop cancer or other illnesses more than usual. Therefore it is important to determine whether it is better to start taking HIV medicines as soon as you know you have HIV or to wait and follow the current guidelines of starting treatment when T-cells go below 350.
Study participants will be randomly assigned to one of two groups:
- Group 1: begins antiretroviral treatment (ART) right away and continues it uninterrupted from then on
- Group 2: delays treatment until their T-cell count drops to 350, then begins antiretroviral treatment, continuing meds uninterrupted from then on; if you are enrolled in Group 2 and you and your doctor agree you should start HIV medicines before your T-cells drop below 350, you may begin taking HIV meds earlier and stay in the study
Participants will be seen for study visits 1 month after enrollment, and then approximately every 4 months for about 3 to 6 years, until the study ends.
Click here to watch a video about The START Study.
- The START study will not be testing new or expirimental medications. You and your healthcare provider will choose the HIV medicines for your treatment. If you develop side effects or your medicines no longer work during the study, you and your provider can decided to change your medicines.
- The study will pay for the exams and laboratory tests that are part of the study. HIV medications may be provided either by the study or by your insurance.
- You will be compensated for your time at each study visit.
http://www.facebook.com/CornellStartStudy
For the convenience of our study participants, we have two locations:
Upper East Side: Baker 24 at NewYork-Presbyterian Hospital/Weill Cornell Medical Center
Disease Status and/or Stage
HIV Antiretroviral Naive (Have Not Taken HIV Medications)
Sponsor
NIH
Key Eligibility
- HIV positive men and women age 18 and older
- CD4+ (T-cell) count ≥ 500
- Antiretroviral naive (have never taken HIV antiretroviral medications)
- More detailed eligibility discussed when you contact the study team
Principal Investigator
Contact
- Valery Hughes, FNP
- (212) 746-4393
- [email protected]
Healthy Volunteers
As a healthy volunteer in a clinical trial you may make a significant contribution to the discovery of medical knowledge and new treatments that could impact people around the world.
Click here for studies seeking healthy volunteers.
Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
