A Phase III, Randomized, Non-inferiority Trial Comparing the Standard Viral Load Based Antiretroviral Monitoring Strategy With a CD4 Based Monitoring Strategy Among Antiretroviral Naive Immunocompromised Adults in Thailand
Sponsor study identifier
NIH
interventional
716
1 country
20
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Actual (reported)Study Completion
December 2011
Actual (reported)The purpose of this study is to determine if a decision to switch to a subsequent antiretroviral regimen based upon the CD4 cell count rather than the standard switching strategy based on viral load could ensure the same immunological and clinical outcome and preserve future treatment options in AIDS patients
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 7, 2005
Actual (reported)September 13, 2005
Actual (reported)April 2010
Actual (reported)December 2011
Actual (reported)Proportion of "clinical failures" defined as confirmed CD4 count below 50/mm3, first or new AIDS-defining event, or death
After 3 years of follow-up
The number of therapeutic options left taking into account drugs exhausted cross-resistance mutations and shared toxicities
After 3 years of follow-up
The secondary endpoint related to safety will be time to the first development of grade 3 or grade 4 sign, symptom, and laboratory abnormality.
During 3 years of follow-up
\* VL-S, the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
CD4-S, the alternative CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
Antiretroviral treatment will use the standard viral load (VL) based monitoring strategy, where switching is performed when VL is confirmed (within one month) above 400 copies per mL.
Antiretroviral treatment is monitored using a CD4 based monitoring strategy where switching is performed when a confirmed (within one month) relative decline in CD4 count of more than 30% from peak values is observed within 200 cells from baseline.
Buddhachinaraj Hospital
Bangkok, Bangkok, 10220, Thailand
Chacheongsao Hospital
Chacheongsao, Chacheongsao, 24000, Thailand
Prapokklao Hospital
Prapokklao, Muang, Changwat Chanthaburi, 22000, Thailand
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, 57110, Thailand
Chonburi Hospital
Muang, Chonburi, Changwat Chon Buri, 20000, Thailand
Regional Health Promotion Centre 6,
Khon Kaen, Changwat Khon Kaen, 40000, Thailand
Lampang Hospital
Lampang, Changwat Lampang, 52000, Thailand
Jourdain G, Ngo-Giang-Huong Nicole, Le Coeur S, Traisaithit P, Barbier S, Techapornroong M, Banchongkit S, Buranabanjasatean S, Halue G, Lallemant M, and The PHPT-3 study group. PHPT-3: A Randomized Clinical Trial Comparing CD4 versus Viral Load (VL) Antiretroviral Therapy Monitoring/Switching Strategies in Thailand. 18th Conference on Retroviruses and Opportunistic Infections, 27 February-2 March, 2011,Boston, USA. Oral Presentation #44.
Cressey TR, Urien S, Hirt D, Halue G, Techapornroong M, Bowonwatanuwong C, Leenasirimakul P, Treluyer JM, Jourdain G, Lallemant M; PHPT-3 Team. Influence of body weight on achieving indinavir concentrations within its therapeutic window in HIV-infected Thai patients receiving indinavir boosted with ritonavir. Ther Drug Monit. 2011 Feb;33(1):25-31. doi: 10.1097/FTD.0b013e3182057f6f.
Jourdain G, Le Coeur S, Ngo-Giang-Huong N, Traisathit P, Cressey TR, Fregonese F, Leurent B, Collins IJ, Techapornroong M, Banchongkit S, Buranabanjasatean S, Halue G, Nilmanat A, Luekamlung N, Klinbuayaem V, Chutanunta A, Kantipong P, Bowonwatanuwong C, Lertkoonalak R, Leenasirimakul P, Tansuphasawasdikul S, Sang-A-Gad P, Pathipvanich P, Thongbuaban S, Wittayapraparat P, Eiamsirikit N, Buranawanitchakorn Y, Yutthakasemsunt N, Winiyakul N, Decker L, Barbier S, Koetsawang S, Sirirungsi W, McIntosh K, Thanprasertsuk S, Lallemant M; PHPT-3 study team. Switching HIV treatment in adults based on CD4 count versus viral load monitoring: a randomized, non-inferiority trial in Thailand. PLoS Med. 2013 Aug;10(8):e1001494. doi: 10.1371/journal.pmed.1001494. Epub 2013 Aug 6.
Marc Lallemant, MD
Institut de Recherche pour le Developpement & Harvard School of Public Health
716 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2005
First Posted
September 13, 2005
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lamphun Hospital
Muang, Changwat Lamphun, 51000, Thailand
Nong Khai Hospital
Muang, Nong Khai, Changwat Nong Khai, 43000, Thailand
Phayao Provincial Hospital
Muang, Changwat Phayao, 56000, Thailand
Ratchaburi Hospital
Muang, Ratchaburi, Changwat Ratchaburi, 70000, Thailand
Rayong Hospital
Rayong, Changwat Rayong, 21000, Thailand
Hat Yai Hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Nakornping Hospital
Mae Rim, Chiang Mai, 50180, Thailand
Sanpatong Hospital
Sanpatong, Chiang Mai, 50120, Thailand
Chiangrai Prachanukroh Hospital
Muang, Chiangrai, Chiangrai, 57000, Thailand
Mahasarakam Hospital
Muang, Mahasarakam, 44000, Thailand
Maharaj Nakornratchasrima Hospital
Muang, Nakornratchasrima, Nakornratchasrima, 30000, Thailand
Samutprakarn Hospital
Samutprakarn, Samutprakarn, 10280, Thailand
Samutsakorn Hospital
Muang, Samutsakorn, Samutsakorn, 74000, Thailand
Primary Completion
April 2010
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 6, 2012
Record last verified: 2012-01
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Source: ClinicalTrials.gov.
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