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| Name | Class |
|---|---|
| Infectious Disease Institute, Kampala, Uganda | OTHER |
| Desmond Tutu HIV Centre | OTHER |
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This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pharmacokinetic parameter Cmin of dolutegravir | Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin | Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pharmacokinetic parameter AUC of dolutegravir | Change in dolutegravir AUC when dosed with standard, medium, high dose rifampicin | Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment |
| Change in pharmacokinetic parameter Cmax of dolutegravir |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saye Khoo | University of Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desmond Tutu Health Foundation | Cape Town | South Africa | ||||
| Infectious Diseases Institute |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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Change in dolutegravir Cmax when dosed with standard, medium, high dose rifampicin |
| Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment |
| Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017) | Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017) | From first dose of dolutegravir until study completion approximately 2 years |
| Kampala |
| Uganda |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |