None listed
Conditions
Interventions
Patients in this group will initiate antiretroviral therapy within 72 hours after randomization and within approximately 2 weeks after the start of TB treatment. Being treated with Efavirenz, in tablets, at a dose of 600 mg, PO, QD + Emtricitabine, in tablets, at a dose of 200 mg, PO, QD + Tenofovir, in tablets, at a dose of 300 mg, PO, QD. This scheme will be administered for 48 weeks.
Group name:ARM B Type of group
Patients in this group will start antiretroviral treatment between 8 and 12 weeks after the start of TB treatment. Being treated with Efavirenz, in tablets, at a dose of 600 mg, PO, QD + Emtricitabine, in tablets, at a dose of 200 mg, PO, QD + Tenofovir, in tablets, at a dose of 300 mg, PO, QD . This scheme will be administered for 48 weeks.
Sponsors
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION,
Eligibility
Inclusion criteria
Inclusion criteria: 1. HIV-1 infection. 2. TB confirmed or probable. 3. X-ray of the chest within 30 days prior to study entry. 4. Current TB treatment based on rifampicin and other rifamycin derivatives initiated within 14 days prior to admission to the study. 5. Amount of CD4 cells <200 cells / mm3 obtained within 30 days before admission to the study in any of the laboratories approved by DAIDS. 6. The following laboratory values ​​obtained within 14 days prior to admission to the study: a) Absolute number of neutrophils ≥ 500 cells / mm3. b) Hemoglobin ≥ 7.0 g / dL. c) Amount of platelets ≥ 50,000 / mm3. d) Estimated creatinine clearance ≥ 60 mL / min. e) AST (SGOT), ALT (SGPT), bilirubin, and alkaline phosphatase ≤ 5 x ULN. 7. Female participants with reproductive potential with a serum or negative urine pregnancy test within 7 days before admission to the study. 8. All participants must agree to avoid any conception process. 9. Female participants who are participating in a sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception. 10. Ability to swallow medications orally. 11. Male and female participants, aged ≥ 13 years. 12 The ability and availability of the participant or the tutor / representative to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Having received at any time prior to admission to the study for> 7 days of cumulative treatment with any ARV or treatment during any period of time with 2 or more ARVs in combination. 2. Breastfeeding. 3. Allergy / sensitivity to any study drug or its formulations. 4. Having a prior history of documented multidrug resistant TB. 5. Having received any research or chemotherapy therapy within 30 days prior to admission to the study. 6. Anticipated reception of any of the prohibited medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical determination of the progression of AIDS, defined as a new disease defining AIDS. Measure:Proportion of participants who have survived without progression of AIDS. Timepoints:Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Evaluation of the severity of adverse events, both physical and laboratory. Criterion 2: Determination of the number of patients who change / continue antiretroviral treatment due to toxicity or treatment failure (defined as 2 successive measurements of HIV-1 RNA plasma ≥ 1000 copies / mL. Measure:Safety and tolerability: 1) Proportion of participants with grade 3 or more of toxicity. 2) Proportion of participants who change / continue ART due to toxicities or failure to treat. Timepoints:Week 48. ; Outcome name:Criterion 1: The final result is defined by the particular national program (NTP) of each research center. Criterion 2: Identify those patients who need to continue with TB treatment for longer time. Measure:Final result of TB treatment: 1) Overall final result. 2) Need for extended TB treatment. Timepoints:Week 48. ; Outcome name:Criterion 1: Determination of those predictors of: a) Immune Reconstitution Syndrome (IRIS). b) Failure to cure TB. c) Recurrence of TB. d) Intolerance to treatment for TB in the presence of ART. Criterion 2: Determination of the response to treatment, using the CD4 count, viral load HIV-1 RNA, viral load time <200 copies / mL and virological failure. Criterion 3: Tests for sensitivity to ARV treatment. Criterion 4: Serum concentration of EFV and NVP + Viral load RNA of HIV-1 + Evaluation of toxicity related to drugs in research. Criterion 5: Determine the proportion of participants with residual levels of EFV less than 1.0 mg / L. Measure:1) Determination of predictors. 2) Response to treatment with ART. 3) Resistance to the drug for HIV. 4) Relationship between the concentrations of EFV and NVP, virological response and toxicities. 5) Determine if the 600 mg dose of EFV provides exposure adequate 6) Impact of confirmed TB. Timepoints:Criteria 1, 2, 3, 5 and 6: Week 48. Criterion 4: Weeks 4 and 8. | — |
Countries
Botswana, Brazil, Congo, Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, United States, Zambia, Zimbabwe
Outcome results
None listed