Ongoing Studies
1 HIV-NAT 001 1996
111
 A randomized, double-blind, comparative trial to evaluate the efficacy of combination therapy with zidovudine (ZDV)  200mg TID plus zalcitabine (ddC) 0.75mg TID versus AZT 100mg TID plus ddC 0.375 mg TID in an antiretroviral-naive Thai study population.
2 HIV-NAT 001.1 1998
95
 A randomized, open-label, follow-up 48-week study to protocol HIV-NAT 001 to explore the antiretroviral efficacy and tolerability of switching to therapy with d4T/ddI/saquinavir soft gel capsules versus Combivir? (ZDV/3TC)/saquinavir soft gel capsules (SQV-SGC) in an HIV-infected Thai population pre-treated with ZDV and ddC for at least 48 weeks.
3 HIV-NAT 001.2 1999
91
 The pharmacokinetics of the interaction between SQV-SGC and itraconazole were studied in plasma and CSF in 17 participants at baseline and after 4 and 24 weeks on study in this extension phase.
4 HIV-NAT 001.3 2000
90
 An open label, follow-up, comparative cohort 48 week study to evaluate the efficacy, safety, pharmacokinetics, and tolerability of SQV-SGC 1600 mg OD / ritonavir (RTV) 100 mg OD plus dual nucleosides in those patients with undetectable viral load (less than 50 copies) and saquinavir-SGC 1400 mg BID plus dual nucleosides in those patients with detectable viral load (greater than 50 copies/mL).
5 HIV-NAT 001.4 2001
88
 An open label, randomized 3-arm study to evaluate the efficacy, safety and tolerability of 1) continuous daily SQV-SGC 1600mg OD/RTV 100mg OD plus dual nucleosides versus 2) STI of the same therapy given for one week on alternating with one week off therapy versus 3) STI of the same therapy which is suspended and re-started based on CD4-driven criteria in patients with an undetectable viral load (<50copies/mL) for greater than six months and CD4 count >350cell/ml.
6 HIV-NAT 002 1996
78
 A randomized, open label, study to compare the safety and biological effects of combinations of didanosine (ddI) and stavudine (d4T) to didanosine monotherapy in antiretroviral na?ve HIV infected subjects with CD4 cell counts of 150-350/uL.
7 HIV_NAT 002.1 1997
71
 A randomized, open label study to explore the antiretroviral efficacy and tolerability of immediate versus deferred switching from ddI/d4T to AZT/3TC in a Thai HIV-1 infected population, pretreated with ddI/d4T.
8 HIV_NAT 002.2 1998
69
 This study incorporated the addition of hydroxyurea as a salvage therapy, otherwise patients continued with their previous regimen from HIV-NAT 002.1.
9 HIV-NAT 003 1997
106
 A randomised, open-label trial to evaluate the tolerability and efficacy of ZDV/3TC/ddI versus AZT/3TC in 106 antiretroviral naive HIV-infected patients in which 101 patients remained on study after 48 weeks.
10 HIV-NAT 003.1 1998
101
 A randomised, open-label follow-up study to protocol HIV-NAT 003 to explore the antiretroviral efficacy of immediate switching to therapy with d4T/ddI versus continued AZT/3TC and deferred switching to d4T/ddI in a population pre-treated with ZDV/3TC for at least 48 weeks and comparing these strategies with continuing AZT/3TC/ddI in a population pre-treated with ZDV/3TC/ddI for at least 48 weeks.
11 HIV-NAT 003.2 1999
101
 An open-label, follow-up study to protocol HIV-NAT 003.1 to explore the durability of the antiretroviral efficacy and tolerability of ZDV/3TC and d4T/ddI in a population originally treated with ZDV/3TC, and of ZDV/3TC/ddI and d4T/3TC/ABC in a population originally treated with ZDV/3TC/ddI, and to explore the efficacy of adding hydroxyurea to the last regimen failed or d4T/3TC/ddI/HU as a salvage regimen.
12 HIV-NAT 005 2000
104
 Randomized trial of indinavir 800mg TID versus indinavir 800/ritonavir100mg BID plus AZT/3TC
13 HI-NAT 009 2001
61
 An open label, single-arm non-randomised study to evaluate the efficacy, safety and tolerability of indinavir 800mg BID plus ritonavir 100mg BD, in combination with efavirenz 600mg OD, in HIV-1 infected patients who are pre-treated with and have failed combination nucleoside reverse transcriptase therapy.
14 2NN 2000
200 Multicentre 
 An open label comparative study to investigate the antiviral efficacy of nevirapine and efavirenz or both these drugs, in combination with stavudine and lamivudine, for the treatment fo HIV-1 infection.
15 HIV-NAT 010 2002
43
 Randomized trial of immediate versus deferred therapy with AZT/3TC/NVP in Thai children with moderate immunodeficiency
16 HIV-NAT 011 2003
2
 A single arm study to assess the use of pharmacokinetically guided indinavir dose reductions in patients with chronic renal impairment from indinavir use
17 E-1696 2001
20 Multicentre
 A phase 3 multicentre, double-blind randomised trial to compare the effects of nandrolone decanoate and placebo on body composition and body weight in HIV-positive men with mild to moderate wasting
18 BMS AI424-008 2000
31 multicentre
 Evaluation of the safety and antiviral efficacy of a novel HIV-1 protease inhibitor, Atazanavir, in combination with d4T and 3TC as compared to a reference combination regimen
19 BMS AI455-044 2001
27
 A study to assess long-term antiviral activity, safety, including serum lipids, and tolerability of Atazanavir in combination with stavudine and lamivudine in subnects previously treated with nelfinavir or atazanavir
20 BMS AI455-099-d4T-ER 2000
15
 The safety and antiviral efficacy of stavudine extended release formulation (d4T ER) as compared to stavudine immediate release formulation, each as part of potent antiretroviral combination therapy
21 HIV-NAT Hepatitis coinfection study 2002
61
 Prevalence of HIV and chronic viral hepatitis co-infection and the effects of antiretroviral therapy on hepatitis outcomes among Thai HIV-infected patients participating in HIV-NAT clinical trials
22 T-20 Pharmacology Study Series 2001
36
 3 sequential crossover studies to investigate the influence of rifampicin, saquinavir/ritonavir and ritonavir alone on the pharmacokinetics of T-20 (Enfuvirtide) in HIV-1 infected patients
23 HIV-NAT 014 2002
50
 The effect of antiretroviral therapy on the cognitive, behavioural and emotional function of Thai children with vertically transmitted HIV infection
24 HIV-NAT 019 2004
48
 Pharmacokinetics and rate of HIV-1 RNA decline in ARV-na?ve HIV-1 infected patients treated with low- or standard-dose saquinavir HCG (Invirase?) and lopinavir/ritonavir (Kaletra?).
25 HIV-NAT 020 2004
50
 Determining factorsand barriers surrounding disclosure and adherence to antiretroviral treatment in HIV-infected Thai children.
26 HIV-NAT 021 2004
25
 Pharmacokinetic comparison of ritonavir and ketoconazole boosting of saquinavir hard-gel capsules
27 HIV-NAT cohort progression study 2003
417
 A retrospective study examining disease progression in a cohort of adult patients treated via a clinical research network in a resource limited setting
28 TMC125-C227 2005
30 Multicentre
 A phase II randomised, active controlled, open label trial to investigate the efficacy and tolerability of TMC125 in HIV-1 infected subjects, who are PI-na?ve and with documented genotypic evidence of NNRTI resistance from previous NNRTI use.
29 2NN long-term follow-up study 2005
196
 A retrospective study to compare the 3 year antiviral efficacy of nevirapine and efavirenz in combination with d4T and 3TC
30 HIV-NAT 012 2000
22
 The effect on HIV-1 elimination rate constant of combination ART aimed at three independent viral targets (fusion inhibitor + reverse transcriptase inhibition + protease inhibition) compared to that aimed at two independent viral targets (reverse transcriptase inhibition + protease inhibition)
31 HIV-NAT -013 2003
95 Multicentre
 Incidence of multi-nucleoside reverse transcriptase inhibitor (NRTI) resistance in children on dual NRTI
32 HIV-NAT 015 2004
60
 Treatment outcome of children with HIV infection treated with highly active antiretroviral therapy (HAART)
33 HIV-NAT 016 2004
15
 Nelfinavir in HIV-1 infected children: PK of dosing based on body surface area versus dosing based on body weight
34 HIV-NAT 017 2004
20
 Lopinavir/r plus saquinavir salvage therapy in HIV-infected children with NRTI and/or NNRTI failure: PL and two-year treatment follow up.
35 HIV-NAT 022 2004
36
 Virological and clinical anti-HBV efficacy of tenofovir in antiretroviral na?ve patients with HIV/HBV co-infection
36 HIV-NAT 023 2005
24
 Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral na?ve patients with HIV/HBV co-infection
37 HIV-NAT 024 2004
30
 A randomised, open. Label, active controlled trial to evaluate the antiviral efficacy and safety of treatment with 500mg tipranavir plus 100mg or 200mg ritonavir po BID in combination with standard background regimen in comparison to 400mg lopinavir plus 100mg ritonavir po BID in combination with standard background regimen in ART na?ve patients for 48 weeks with extension up to 156 weeks
38 HIV-NAT 025 2005
75
 Protocol for the collection of nevirapine PK data in Thai patients with HIV and TB co-infection on nevirapine and rifampicin
39 HIV-NAT 026 2005
experiment
 Quality control program for generic verses branded drugs (Pilot)
40 HIV-NAT 027 2005
30
 Efficacy and safety of a saquinavir based regimen in HIV-1 infected Thai patients who have chronic IDV associated nephrotoxicity
41 HIV-NAT 028 2005
58
 Follow-up study of bio-equivalence study of generic GPO saquinavir tablets versus Invirase? in Thai healthy volunteers
42 HIV-NAT 030 2005
Planned
 Surveillance of generic post marketed antiretrovirals
43 HIV-NAT 031 2005
Planned
 Study of genetic polymorphisms of CYP 3AQ and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir
44 HIV-NAT032 2005
36
 Generation of HBV-specific T-cell immunity in individuals with HIV/HBV co-infection receiving HBV-active antiretroviral therapy
45 ESPRIT 2001
216 Multicentre
 A randomised, open label phase 3 international study of subcutaneous recombinant interleukin-2 (Proleukin?) in patients with HIV infection and CD4+ lymphocyte ?350cells/mm3.
46 STACCATO 2001
350 Multicentre
 Randomized trial of continuous versus interrupted ART
47 TAHOD 2002
200 Multicentre
 The treat Asia HIV observational Database: a study to collect observational data on HIV-infected patients froma  number of sites in several Asian countries
48 T-20 Rollover 2003
36
 A phase 3 open-label uncontrolled ‘roll over’ safety study of enfuvirtide in combination with free choice of background antiretrovirals, in patients who have participated in prior enfuvirtide clinical pharmacology studies
49 NRTI failure 2004
10 Multicentre
 An open label, randomised study to evaluate the efficacy, safety, and tolerability of dual boosted protease inhibitor therapy with lopinavir/r 400mg/100mg BID plus saquinavir 1000mg BID versus ritonavir boosted indinavir (100mg/100mg BID) plus two nucleoside reverse transcriptase inhibitors chosen by genotypic resistance testing in patients failing NNRTI/NRTI combination therapy
50 HIV-NAT 006 2001
300
 A long-term, post-study follow-up of HIV-infected patients who previous participated in HIV-NAT study protocols
51 PREDICT 2005
Multicentre
 An open labelled, randomized study to compare antiretroviral therapy (ART) initiation when CD4+ is between15-24% to ART initiation when CD4+ falls below 15% in children with HIV infection and moderate immune suppression
52 TMC 278  2005
Multicentre
 A Phase IIb randomised, partially blinded, dose-finding trial of TMC278 in antiretroviral na?ve HIV-1 infected subjects
53 Smart 2005
Multicentre
 A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
54 HIV-NAT032 2005
36
 Generation of HBV-specific T-cell immunity in individuals with HIV/HBV co-infection receiving HBV-active antiretroviral therapy
55 HIV/TB 2005
100 Multicentre
 A 48 week, randomized, open-label, 2 arm study to compare the efficacy, safety and tolerability of HAART containing nevirapine 400mg/day versus nevirapine 600 mg/day in HIV-1 infected patients started at 2-6 weeks after initiating rifampin containing anti-tuberculosis therapy
56 Gemini 2005
60 Multicentre
 A 48-week, randomized, open-label, 2-arm study to compare the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-na?ve HIV-1 infected patients (Gemini Study)
 
 
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