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TB is the most common cause of death in patients with HIV worldwide. Rifampicin [RIF] is the cornerstone of anti-TB therapy. Current guideline recommend efavirenz (EFV) 600mg per day as the first of choice for HIV/TB co-infection. Co-administration of EFV with RIF decrease the plasma concentration of EFV. Because of better safety profiles, EFV 400mg has replaced the EFV 600mg as the first-line antiretroviral therapy in people living with HIV. However, the efficacy of EFV 400mg when co-administrated with RIF in HIV/TB co-infection is unclear. This study is designed to evaluate the efficacy and safety of EFV 400mg versus EFV 600mg in HIV/TB co-infected patients receiving RIF based anti-TB therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial | Experimental | EFV 400mg |
|
| Control | Active Comparator | EFV 600mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz 600mg | Drug | EFV 600 mg per day given orally |
| |
| Efavirenz 400mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/Milliliter at Week 48 Using the US Food and Drug Administration (FDA) Snapshot Algorithm | The percentage of participants who were responders was assessed at the study Week 48 for participants randomized to receive at least one dose of study medication. Response was assessed using a modified FDA Snapshot algorithm | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/Milliliter at Week24 Using the US Food and Drug Administration (FDA) Snapshot Algorithm | The percentage of participants who were responders was assessed at the study Week 24 for participants randomized to receive at least one dose of study medication. Response was assessed using a modified FDA Snapshot algorithm | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Chen, M.D | Contact | +86-21-37990333 | 3222 | qtchenjun@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Chen, M.D | Shanghai Public Health Clinical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| Drug |
2 tablets of EFV 200 mg per day given orally |
|
| Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 | Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) is presented by treatment group. | Week 24 and Week 48 |
| Number of Participants With Tuberculosis (TB) Associated Immune Reconstitution Inflammatory Syndrome (IRIS) | Participants were monitored for signs and symptoms of TB-IRIS. Participants with IRIS symptoms in any adverse events or HIV associated. conditions were classified by the study investigators in the following categories as met criteria for TB-IRIS, possibly met criteria for TB-IRIS and suspected TB-IRIS but not possible to adjudicate. | Week 12 |
| 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 |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |