Strategic Timing of Antiretroviral Treatment (START)
This study is currently recruiting participants.
Verified May 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00867048
First received: March 20, 2009
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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 cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines.
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Drug: All licensed antiretroviral medications |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Strategic Timing of AntiRetroviral Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Components of the composite primary outcome measure [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Specific non-AIDS diagnoses [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Hospitalization, health-care utilization, quality of life [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- HIV drug resistance and transmission risk behavior [ Time Frame: 4.5 years ] [ Designated as safety issue: Yes ]
- Change in neurocognitive function (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) [ Time Frame: Blood taken at study entry and stored in a central repository indefinitely ] [ Designated as safety issue: No ]
- Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) [ Time Frame: Before randomization into START ] [ Designated as safety issue: No ]
- Large and small artery elasticity (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Rate of lung function decline (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
- Changes in bone mineral density (in a subset of participants) [ Time Frame: 4.5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early ART
Initiate ART immediately following randomization
|
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
|
|
Active Comparator: Deferred ART
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
|
Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 including but not limited to 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 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 interleukin-2 (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
- Diagnosis of decompensated liver disease before randomization
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867048
Show 221 Study Locations
Show 221 Study LocationsSponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council (MRC) Clinical Trials Unit -- London, United Kingdom
The Kirby Institute for Infection and Immunity in Society
The Institute for Clinical Research at the Veterans Affairs Medical Center -- Washington, D.C., USA
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck
Tibotec Pharmaceutical Limited
Investigators
| Principal Investigator: | James D Neaton, PhD | University of Minnesota - Clinical and Translational Science Institute |
| Study Chair: | Abdel Babiker, PhD | Medical Research Council Clinical Trials Unit, London |
| Study Chair: | Sean Emery, PhD | National Centre in HIV Epidemiology & Clinical Research, UNSW, Sydney |
| Study Chair: | Fred Gordin, MD | Veterans Affairs Medical Center -- Washington, DC |
| Study Chair: | Jens Lundgren, MD, DMSc | Copenhagen HIV Programme |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00867048 History of Changes |
| Obsolete Identifiers: | NCT00821171 |
| Other Study ID Numbers: | 0603M83587, U01AI068641, 2008-006439-12 |
| Study First Received: | March 20, 2009 |
| Last Updated: | May 9, 2013 |
| Health Authority: | Argentina: Ministry of Health Australia: National Health and Medical Research Council Austria: Federal Office for Safety in Health Care Belgium: Institutional Review Board Brazil: Ethics Committee Chile: Instituto de Salud Publica de Chile Czech Republic: Ethics Committee Denmark: Ethics Committee Estonia: Research Ethics Committee European Union: European Medicines Agency Finland: Ethics Committee France: National Consultative Ethics Committee for Health and Life Sciences Germany: Ethics Commission Greece: Ethics Committee India: Indian Council of Medical Research Ireland: Research Ethics Committee Israel: Ethics Commission Italy: National Bioethics Committee Luxembourg: Comite National d'Ethique de Recherche Mali: Ministry of Health Mexico: Ethics Committee Morocco: Ministry of Public Health Nigeria: The National Agency for Food and Drug Administration and Control Peru: Ethics Committee Poland: Ethics Committee Portugal: Ethics Committee for Clinical Research South Africa: National Health Research Ethics Council Spain: Ethics Committee Sweden: Regional Ethical Review Board Switzerland: Ethikkommission Thailand: Ethical Committee Uganda: National Council for Science and Technology United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
highly active antiretroviral therapy (HAART) CD4 Count Early Intervention HIV |
HIV Infection HIV Infections treatment naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013