Table 2.
Trial efficacy from randomisation to week 48 assessment
| Short cycle therapy (n=99) | Continuous therapy (n=100) | p value | ||||
|---|---|---|---|---|---|---|
| Primary endpoint | ||||||
| Participants with confirmed viral load ≥50 copies/mL | 6 (6%) | 7 (7%) | 0·75 | |||
| Secondary endpoints | ||||||
| Participants with confirmed viral load ≥400 copies/mL | 2 (2%) | 4 (4%) | 0·38 | |||
| Participants with change in ART regimen | 3 (3%) | 9 (9%) | 0·13 | |||
| Viral rebound | 0 | 1 | .. | |||
| Toxicity* | 1 | 4 | .. | |||
| Adherence problems | 1 | 1 | .. | |||
| Simplification | 1 | 3 | .. | |||
| Participants with mutations present at viral rebound† (participants with resistance test result available) | 2 (3) | 5 (6) | 1·00 | |||
| Number of NNRTI mutations | ||||||
| None | 1 | 1 | .. | |||
| 1–2 | 1 | 5 | .. | |||
| 3 or more | 1 | 0 | .. | |||
| Number of NRTI mutations | ||||||
| None | 2 | 5 | .. | |||
| 1 | 1 | 1 | .. | |||
| Mean change in CD4 percentage (%) | 0·2% (0·4) | 0·1% (0·4) | 0·76 | |||
| Mean change in absolute CD4 count (cells per μL) | −34·2 (20·9) | −21·6 (21·1) | 0·67 | |||
| Substudy results | n=98 | n=94 | ||||
| Viral load | ||||||
| ≥20 copies/mL at week 48 | 13 (13%) | 14 (15%) | 0·84 | |||
| <20 copies/mL at week 48 | 85 (87%) | 80 (85%) | ||||
| Mean change in total HIV-1 DNA (Ln copies per million cells) | 0·1 (0·1) | −0·2 (0·1) | 0·13 | |||
| Mean change in interleukin 6 (Ln pg/mL) | 0·0 (0·1) | 0·1 (0·1) | 0·64 | |||
| Mean change in D-dimers (Ln ng/mL) | −0·5 (0·2) | −0·0 (0·2) | 0·05 | |||
Data are n (%) or mean change from randomisation (SE), unless otherwise stated. ART=antiretroviral therapy. NRTI=nucleoside/nucleotide reverse transcriptase inhibitors. NNRTI=non-nucleoside reverse transcriptase inhibitor. Ln=natural logarithm.
One gynaecomastia in the short cycle therapy group, three lipodystrophy events with onset before baseline in the continuous therapy group, and one raised transaminases in the continuous therapy group.
Two participants on short cycle therapy: (1) Leu100Ile, Lys103Asn, Tyr188Cys and (2) Lys103Asn, Met184Val; five participants on continuous therapy: (1) Val106, Glu138Ala, (2) Lys103Asn, Val106Met, (3) Met230Leu, (4) Lys103Asn, Val106Met, and (5) Met184Val, Glys190Ser; samples from four additional patients (three in the short cycle therapy group and one in the continuous therapy group) with low level viraemia failed to amplify.