Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand
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
1 other identifier
interventional
716
1 country
20
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started May 2005
Longer than P75 for phase_3 hiv-infections
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 6, 2012
January 1, 2012
4.9 years
September 7, 2005
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Study Arms (2)
1
ACTIVE COMPARATOR\* 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.
2
EXPERIMENTALCD4-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.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- Eligible patients fulfilling the following criteria can be enrolled in the study:
- Meeting all eligibility criteria
- Two CD4+ cell counts between 50 and 250 cells/mm3 performed within the last six months before enrolment (CD4 cell count should be assessed at least 2 weeks apart from any acute infection)
- Willingness to modify antiretroviral therapy in accordance with the randomized switching scheme assignment
- Subject understands that study drugs will be supplied for free by the study only during participation in the study. After discontinuation of the study, patients will be taken care of in the National ARV Access Program.
- For women, pregnancy
- For women of child bearing potential, lack of willingness to follow an effective method of contraception (in case, during the study, a woman wants to become pregnant or becomes pregnant, she should inform the physician immediately for best therapeutic decision)
- Chronic hepatitis B or C
- Acute hepatitis within 30 days of study entry.
- Acute HIV infection, as it can be established with the date of last negative serology less than one year before enrollment and the history of the patient disease
- Co-enrollment in another study without prior written agreement of the study team
- Psycho-social environment or condition which, in the physician's opinion, makes adherence to the protocol highly unlikely.
- Pre-existing diabetes mellitus (prior gestational diabetes is allowed).
- The following laboratory values: hemoglobin \< 8.0 mg/dl, absolute neutrophil count \< 1000 cells/mm3, ALT, AST or total bilirubin value \> 5.0 x ULN, serum creatinine \> 1.0 x ULN, platelet count \< 50,000/mm3, pancreatic amylase \>2.0 x ULN or lipase \> 2.0 X ULN, or total amylase \> 2.0 X ULN plus symptoms of pancreatitis.
- Severe illness, grade 3 or 4 laboratory exam values not resolved within one month of enrollment without previous agreement of the PHPT attending physician
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
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
Related Publications (3)
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.
RESULTCressey 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.
PMID: 21233689RESULTJourdain 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.
PMID: 23940461DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Lallemant, MD
Institut de Recherche pour le Developpement & Harvard School of Public Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 13, 2005
Study Start
May 1, 2005
Primary Completion
April 1, 2010
Study Completion
December 1, 2011
Last Updated
January 6, 2012
Record last verified: 2012-01