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Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previous vicriviroc 30 mg QD | Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial. |
| |
| Previous vicriviroc 20 mg QD | Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial. |
| |
| Control Group | Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vicriviroc maleate | Drug | Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death. | Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available. | Every 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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The registry will enroll subjects who received vicriviroc or control in a Phase 2 or 3 clinical trial (with the exception of P03802 and ACTG A5211 [and its rollover P04100]), and are no longer receiving study medication.
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|
| Vicriviroc maleate | Drug | Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol. |
|
|
| Placebo | Drug | Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol. |
|
| Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg | Drug | Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol. |
|
|
| 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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| ID | Term |
|---|---|
| C486781 | vicriviroc |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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