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| Name | Class |
|---|---|
| Queen Savang Vadhana Memorial Hospital, Thailand | OTHER |
| Thai Red Cross AIDS Research Centre | OTHER |
| University of Hawaii | OTHER |
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This protocol aims to determine the risk/benefits of this policy by comparing head-to-head a regimen of GPO-VIR Z or TDF/FTC/NVP for 18 months in ARV-naïve patients to a 6-month lead in with GPO-VIR S followed by 12 months of GPO-VIR Z. The primary outcomes to be assessed will be anemia, neuropathy, lipoatrophy and renal function.
GPO-VIR Z is a new combination antiretroviral (ARV) medication that substitutes zidovudine (AZT) for stavudine (d4T) from the original formulation of GPO-VIR S. This new combination should decrease rates of lipoatrophy and neuropathy which are side-effects strongly linked to the use of d4T. However, there is some risk that initiating therapy with an AZT- containing regimen may cause unacceptable rates of anemia. Many Thai physicians have adopted a practice of using 6 months of the stavudine-containing GPO-VIR S as a lead in before introducing AZT-containing GPO-VIR Z in an effort to balance the risks and benefits of these two medications. There are no definitive data, however, that can attest to the benefit of such an approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. GPO-VIR S 1 pill orally every 12 hours | Experimental |
| |
| 2 GPO-VIR Z 1 pill orally every 12 hours | Experimental |
| |
| 3 Truvada 1 pill oral q 24 hr and NVP 1 pill oral q 12 hr | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP | Drug | Truvada(FTC200mg+TDF300mg) every 24 hours + NVP 200 mg every 12 hours orally until week 72 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean hemoglobin at 24 weeks and 72 weeks | 72 weeks | |
| Proportion of participants with peripheral neuropathy at 24 weeks and 72 weeks | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in body weight, limb fat, and lean body mass by DEXA scan at 24 weeks and 72 weeks | 72 weeks | |
| Change from baseline in serum creatinine at 24 weeks and 72 weeks | 72 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jintanat - Ananworanich, M.D. | SEARCH Thailand | Principal Investigator |
| Jintanat - Ananworanich, M.D., Ph.D | SEARCH Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEARCH Thailand | Bangkok | Bangkok | 10330 | Thailand |
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| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP | Drug | GPO-VIR S(D4T30mg+3TC150mg+NVP200mg)1 pill orally every 12 hours until week 24 and then switch to GPO-VIR Z |
|
| AZT/3TC/NVP, AZT/D4T/NVP, Truvada/NVP | Drug | GPO-VIR Z(AZT250mg+3TC150mg+NVP200mg) 1 pill orally every 12 hours until week 72 |
|
| Proportion of participants with plasma HIV-1 RNA less than 50 copies/mL at 24 weeks and 72 weeks |
| 72 weeks |
| Change from baseline in CD4 count at 24 weeks and 72 weeks | 72 weeks |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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