Protocol Number: 09-I-0108

Title:

Strategic Timing of AntiRetroviral Treatment (START)

Number:

09-I-0108

Summary:

Background:

- Most guidelines agree that if a person's number of CD4+ cells (white blood cells that help fight infection) drops below 350 cells/mm3, or that person has symptoms of AIDS, he or she should start taking HIV medicines. The data supporting this recommendation are stronger for those with CD4+ cell counts < 200 cells/mm3 than for those with CD4+ counts between 200 and 350 cells/mm3. However, there is very little evidence to prove that this is always a good choice.

- In some studies, people who took HIV medicines and kept their CD4+ cell counts higher than the standard recommended number had fewer serious illnesses than people not taking HIV medicines. However, researchers do not entirely understand why this happens.

Objectives:

- To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their CD4+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level recommended by the guidelines.

- To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

Eligibility:

- Patients 18 years of age and older who are infected with HIV, have CD4+ cell counts of greater than 500 cells/mm3, and who have never had antiretroviral therapy to treat HIV.

Design:

- Initial screening visits (2) to draw blood for CD4+ cell counts and provide a full medical history

- Patients will be randomly split into two groups:

Early: Patients will begin receiving HIV medications from the start of the study.

Deferred: Patients will begin to take HIV medications at the time recommended by current guidelines.

- HIV medications for each patient will be determined by the study doctors.

- Evaluations during the treatment period:

-Physical examination, including vital signs and body weight checks, and pregnancy test for women who can become pregnant.

-Questions about daily life, including sexual behaviors.

-Blood and urine tests.

-Heart tests with electrocardiogram.

- Patients will return for evaluations every 4 months for the duration of the study.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

- Signed informed consent

- HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed* ELISA test; and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.

- Age greater than or equal to 18 years

- Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)

- Perceived life expectancy of at least 6 months

- For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed

- Two consecutive CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization

*The term licensed refers to an FDA-approved kit or, for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country. Confirmation of the initial test result must use a test method that is different than the one used for the initial assessment.

EXCLUSION CRITERIA:

- Any previous use of ART or IL-2

- Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection)

- Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever

- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization

- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization

- Dialysis within 6 months before randomization

- History of decompensated liver disease

- Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness

- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential)

Special Instructions:

Currently Not Provided

Keywords:

HAART

CD4 Count

Early Intervention

Recruitment Keyword(s):

HIV

HIV Infection

Condition(s):

HIV Infection

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: All licensed antiretroviral medications

Behavioral: Questionnaires

Supporting Site:

University of Minnesota

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Egger M, May M, Ch�ne G, Phillips AN, Ledergerber B, Dabis F, Costagliola D, D'Arminio Monforte A, de Wolf F, Reiss P, Lundgren JD, Justice AC, Staszewski S, Leport C, Hogg RS, Sabin CA, Gill MJ, Salzberger B, Sterne JA; ART Cohort Collaboration. Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet. 2002 Jul 13;360(9327):119-29. Erratum in: Lancet 2002 Oct 12;360(9340):1178.

May M, Sterne JA, Sabin C, Costagliola D, Justice AC, Thi�baut R, Gill J, Phillips A, Reiss P, Hogg R, Ledergerber B, D'Arminio Monforte A, Schmeisser N, Staszewski S, Egger M; Antiretroviral Therapy (ART) Cohort Collaboration. Prognosis of HIV-1-infected patients up to 5 years after initiation of HAART: collaborative analysis of prospective studies. AIDS. 2007 May 31;21(9):1185-97.

Silverberg MJ, Neuhaus J, Bower M, Gey D, Hatzakis A, Henry K, Hidalgo J, Lourtau L, Neaton JD, Tambussi G, Abrams DI. Risk of cancers during interrupted antiretroviral therapy in the SMART study. AIDS. 2007 Sep 12;21(14):1957-63.

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