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The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.
Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600mg BID ATC | Experimental | 600mg BID ATC |
|
| 800mg BID ATC | Experimental | 800mg BID ATC |
|
| 150mg BID 3TC | Active Comparator | 150mg BID 3TC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVX754 | Drug | apricitabine, 600mg BID or 800mg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HIV RNA levels at day 21 | day 21 | |
| Time-weighted average change from baseline in HIV RNA levels through 21 days | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HIV RNA levels at days 7, 14, 21 | days 7, 14, 21 | |
| Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48 | days 7, 14, 21, and weeks 24 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan W Cox, Ph D | Avexa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avexa (co-ordinating sites in Australia and Argentina) | Melbourne | Victoria | 3121 | Australia |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C508042 | apricitabine |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| 3TC | Drug | 3TC, 150mg BID |
|
|
| Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48 | day 21 and weeks 24 and 48 |
| 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 |
| D012897 | Slow Virus Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |