| 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) |