Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN66756285 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CIHR Canadian HIV Trials Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily |
|
| Valacyclovir | Experimental | oral valacyclovir 500mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valacyclovir | Drug | oral valacyclovir 500mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first. | up to 5 years | |
| Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time |
| Measure | Description | Time Frame |
|---|---|---|
| analysis of inflammatory markers in HIV disease progression, HIV Resistance Mutations and other herpesvirus serologies | up to 6 years | |
| genetic testing of HLA-B*5701 and HLA-B*5703 status, and future genetic markers related to HIV disease progression and the impact of herpes and valacyclovir |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon L Walmsley, MD FRCPC MSc | University Health Network, Toronto | Principal Investigator |
| Darrell HS Tan, MD FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Huesped | Buenos Aires | C1202ABB | Argentina | |||
| Instituto de Pesquisa Clínica Evandro Chagas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21106086 | Background | Tan DH, Raboud JM, Kaul R, Grinsztejn B, Cahn P, Walmsley SL. Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial. Trials. 2010 Nov 24;11:113. doi: 10.1186/1745-6215-11-113. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily |
|
| up to 5 years |
| Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up | up to 5 years |
| Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine) | up to 5 years |
| Frequency of episodes of HSV reactivations at any anatomic site | up to 5 years |
| Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV | up to 5 years |
| Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point | up to 5 years |
| up to 5 years |
| Rio de Janeiro |
| Brazil |
| Ambulatorio de Infectologia da UNIFESP | São Paulo | 04040-002 | Brazil |
| Centro de Referencia e Treinamento em DST/AIDS | São Paulo | 04121-000 | Brazil |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| B.C. Women's Hospital & Health Centre - Oak Tree Clinic | Vancouver | British Columbia | V6H 1N1 | Canada |
| Vancouver Infectious Disease Clinic | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Cool Aid Community Health Centre | Victoria | British Columbia | V8W 1M8 | Canada |
| CDHA, QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| McMaster University Health Sciences Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| The Ottawa Hospital, General Campus Divsions of Infectious Diseases | Ottawa | Ontario | K1H 8L6 | Canada |
| University of Ottawa Health Services | Ottawa | Ontario | K1N 6N5 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M2N 3M5 | Canada |
| St. Clair Medical Associates | Toronto | Ontario | M4K 1N1 | Canada |
| Maple Leaf Medical Clinic | Toronto | Ontario | M5B 1L6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| Windsor Regional Hospital | Windsor | Ontario | N8W 1E3 | Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2L 4M1 | Canada |
| Montreal Chest Institute | Montreal | Quebec | H2X 2P4 | Canada |
| Centre Hospitalier Universitaire de Quebec-Pavillon CHUL | Québec | G1V 4G2 | Canada |
| Brighton & Sussex University Hospitals NHS Trust | Brighton | BN2 1ES | United Kingdom |
| Guy's and St. Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| St. Stephen's AIDS Trust | London | SW10 9NH | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006558 | Herpes Genitalis |
| 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 |
| D006561 | Herpes Simplex |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided