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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00027352




Registration number
NCT00027352
Ethics application status
Date submitted
4/12/2001
Date registered
5/12/2001
Date last updated
25/11/2009

Titles & IDs
Public title
A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
Scientific title
A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Secondary ID [1] 0 0
SMART
Secondary ID [2] 0 0
CPCRA 065
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Note: Enrollment into this trial was halted 01/11/06.



* 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
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Prahran Market Clinic - South Yarra
Recruitment hospital [3] 0 0
The Centre Clinic - South Yarra
Recruitment hospital [4] 0 0
Burwood Street General Pratice - Burwood Nsw
Recruitment hospital [5] 0 0
Royal Perth Hosp - Perth
Recruitment hospital [6] 0 0
Alfred Hosp - Prahan
Recruitment hospital [7] 0 0
Royal Prince Alfred Hospital - Prahan
Recruitment hospital [8] 0 0
National Centre in HIV Epidemiology and Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- South Yarra
Recruitment postcode(s) [3] 0 0
2134 - Burwood Nsw
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Prahan
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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New Jersey
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Plata
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Argentina
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Mendoza
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Argentina
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Rosario
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Austria
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Vienna
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Belgium
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Antwerp
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Belgium
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Liege
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Brazil
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RJ
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Brazil
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RS
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Brazil
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S.p. Cep
Country [35] 0 0
Brazil
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Boqueirao-Santos
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Brazil
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Porto Alegre-RS Cep
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Brazil
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Rio de Janeiro
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Brazil
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Salvador-BA
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Brazil
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San Paulo
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Estonia
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Tallinn
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France
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Annecy
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France
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Bordeaux
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France
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Chu-grenoble
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France
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Colombes
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France
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Marseille
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France
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Paris
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Germany
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Essen
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Germany
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Frankfort
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Germany
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Heidelberg
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Germany
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Zurich Ch-
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Ireland
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Dublin 8
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Israel
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Tel Aviv
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Italy
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Antella-Firenze
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Italy
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Asti
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Italy
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Brescia
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Italy
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Busto Arsizio (va)
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Italy
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Modena
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Italy
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Pavia
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Italy
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Rome
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Italy
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Torino
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Italy
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Torrette Di Ancona
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Italy
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Venice
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Japan
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Tokyo
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Lithuania
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Vilnius
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Luxembourg
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Barble
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Martinique
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Fort-de-france
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Norway
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Oslo
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Peru
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Lima
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Poland
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Koszarowa Str. 5
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Puerto Rico
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Curitiba
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Barcelona
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Madrid
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Sevilla
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Spain
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Terrassa
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Spain
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Valencia
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Switzerland
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Basel Ch
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Switzerland
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Bern
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Switzerland
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La Chaux-de-Fonds
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Thailand
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Chiang Mai
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Thailand
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Nonthaburi 11000
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United Kingdom
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England
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Carshalton, Surrey
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United Kingdom
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Carshalton
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United Kingdom
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Essex
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United Kingdom
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Halifax
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United Kingdom
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London
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United Kingdom
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Middlesbrough
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United Kingdom
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Middlesex
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United Kingdom
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Newcastle
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United Kingdom
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Sheffield
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United Kingdom
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Watford Wd

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wafaa El-Sadr, MD, MPH
Address 0 0
Harlem AIDS Treatment Group, Harlem Hospital Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00027352