Oral abstracts of the 10th IAS Conference on HIV Science, 21‐24 July 2019, Mexico City, Mexico
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Background: Double-dose raltegravir is recommended in HIV1infected patients with tuberculosis. A previous phase 2 study showed similar efficacy of standard raltegravir 400 mg BID, raltegravir 800 mg BID, or efavirenz-based regimens. We aimed to assess noninferiority of raltegravir 400 mg BID to efavirenz in HIV1-infected patients with tuberculosis. Methods: ANRS 12300 Reflate TB2 is an open-label, phase 3, randomized trial conducted in Brazil, Cte d'Ivoire, France, Mozambique, and Vietnam. ART-na ve HIV1-infected patients aged 18 years on standard tuberculosis treatment for to weeks were randomized (1:1) to receive raltegravir 400 mg BID or efavirenz 600 mg QD both with TDF/3TC 300 mg/300 mg QD. The primary endpoint was the proportion of patients with virologic success at week 48 defined as HIV-RNA 50 cp/ml on allocated therapy using the FDA snapshot algorithm. The pre-specified non-inferiority margin was 12%. Results: From September 2015 to January 2018, 230 patients were randomized in each trial arm: 201 (87%) and 203 (88%) completed follow-up in the EFV and RAL arms, respectively. Median age was 35 (IQR: 2 to 3) years, 40% were female, median BMI 19.1 (IQR: 17. to 1.0) kg/m 2 , median CD4 102 (IQR: 38 to 239) cells/L, median HIV-RNA was 5.5 log (IQR: 5.0 to 5.8), 311 (68%) patients had pulmonary tuberculosis only, and 308 (68%) had bacteriologically-confirmed tuberculosis. In the mITT population, virologic success was achieved: in 134/228 (59%) pts in the raltegravir arm and 135/227 (59%) pts in the efavirenz arm at W24 (end of TB treatment); in 139/ 228 (61%) patients in the raltegravir arm and 150/227 (66%) patients in the efavirenz arm at W48. At W48, the difference between the raltegravir and efavirenz arm was -5.1% (95% CI: -13.9-+3.7), thus not meeting criteria for non-inferiority. Sixty-two (27%) and 77 (33%) patients experienced grade 3 to 4 adverse events in the raltegravir and efavirenz arms, respectively (p = 0.1), including 11 (5%) and 13 (6%) IRIS (p = 0.7). Twelve (5%) patients in the raltegravir arm and 14 (6%) in the efavirenz arm died (Logrank p = 0.7). Conclusions: The non-inferiority of raltegravir 400 mg compared to efavirenz at week 48 was not demonstrated. Raltegravir remains a safe option in combination with tuberculosis treatment. Complementary analyses are necessary to identify determinants of virologic failures in both arms.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it