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Prevention of HIV-1 Infection with Early Antiretroviral Therapy

2011 · paper · Clinical trials

A randomized trial in 1763 couples with one HIV-positive partner, comparing immediate with delayed antiretroviral therapy. Early therapy cut linked HIV transmission to the uninfected partner (1 case versus 27) and reduced clinical events, indicating personal and public health benefits.

1 finding

Substance In Table 1 (p.15), the plasma RNA viral-load rows for delayed therapy (N = 877), "43 (5)", "33 (4)", "183 (21)", "432 (49)", "186 (21)", "4 (<1)", sum to 881, not 877.
  • p. 15 Table 1, Plasma RNA viral load rows, Delayed Therapy (HIV-1–infected) column
    432 (49)
  • p. 15 Table 1, plasma RNA viral load, delayed therapy
    43 (5) / 33 (4) / 183 (21) / 432 (49) / 186 (21) / 4 (<1)
  • p. 15 Table 1, Plasma RNA viral load, delayed therapy column
    43 (5) 33 (4) 183 (21) 432 (49) 186 (21) 4 (<1)
  • p. 15 Table 1, plasma RNA viral load, delayed therapy (N=877)
    43 (5)

Only the authors can say what is right here.

Judge's note: The page-15 crop confirms the counts. The categories do not overlap and include a missing-data row. The early-therapy column sums exactly to 886, and no footnote explains the extra 4. It is unclear which count is wrong: 428/877 would still round to 49%, so only the authors can say.

Second check: another model agreed

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9 minor (typos and the like; most checked by the judge only)
Wording P.6 says "Of all treated participants, 66% initiated a second-line regimen." Read literally, the denominator (all treated participants) is implausible.
  • p. 6 Results, first paragraph
    Of all treated participants, 66% initiated a second-line regimen.
  • p. 4 Methods, Antiretroviral Drugs
    For participants with virologic failure, specified second-line treatment regimens were provided.

Only the authors can say what is right here.

Judge's note: About 886+184 = 1070 participants were treated, and 66% of them is about 706. The Methods (p.4) say second-line regimens were provided for virologic failure, which the same paragraph reports in only 45+5 = 50 participants. The denominator was presumably the participants with virologic failure, but only the authors can say.

Second check: another model agreed

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Wording P.5 says "The majority of couples (97%) were heterosexual", but the Table 1 counts give 1725/1763 = 97.8%, which rounds to 98%.
  • p. 5 Results, Study Participants
    The majority of couples (97%) were heterosexual
  • p. 15 Table 1, type of serodiscordancy
    HIV-positive man, HIV-negative man 18 (2)

Only the authors can say what is right here.

Judge's note: In Table 1 the heterosexual couple types are 436+431 (early) and 417+441 (delayed), 1725 of 1763 in total. The other percentages in the same paragraph are conventionally rounded (1291/1763 = 73.2%, printed 73%), so 97% looks like truncation or a slip. The difference is trivial.

Second check: another model agreed

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Wording The Discussion (p.7) says "The majority of HIV-1 transmissions (82%) were observed in Africa", but 82% is 23 of the 28 linked transmissions only, not all 39.
  • p. 7 Discussion, paragraph 2
    The majority of HIV-1 transmissions (82%) were observed in Africa.
  • p. 6 Results, Primary Prevention Outcome
    Of the 28 linked transmissions, 23 (82%) occurred at African sites.

Judge's note: The Results (p.6) say "Of the 28 linked transmissions, 23 (82%) occurred at African sites." The paragraph just before the Discussion sentence reports both linked (28) and total (39) transmissions. The sentence should say "linked".

Second check: another model agreed

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Typo Misspelling on p.2: "All study participants provided written nformed consent" should read "informed consent".
  • p. 2 Methods, Study Population, second paragraph
    written nformed consent
  • p. 2
    written nformed consent in their

Judge's note: The page-2 crop shows "nformed" as printed, so this is not a text-layer artefact.

Second check: none (judge only)

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Typo Unmatched closing parenthesis on p.5: "886 couples were randomly assigned to the early-therapy group and 877 to the delayed-therapy group) (Fig. 1".
  • p. 5 Results, Study Participants, first sentence
    877 to the delayed-therapy group) (Fig. 1

Judge's note: The page-5 crop shows a closing parenthesis with no matching opening parenthesis earlier in the sentence.

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Typo Missing closing parenthesis on p.6: "(hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P = 0.01 (Table 2, and the Supplementary Appendix)".
  • p. 6 Results, Primary Treatment Outcome
    0.40 to 0.88; P = 0.01

Judge's note: The page-6 crop shows that the parenthesis opened at "(hazard ratio" is never closed before "(Table 2".

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Typo The Appendix affiliation on p.9 reads "the Y.R. Gaitonade Center for AIDS Research and Education, Chennai"; the institution's name is probably spelled "Gaitonde".
  • p. 9 Appendix, author affiliations
    Y.R. Gaitonade

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: that the Chennai institution's spelling is "Y.R. Gaitonde". The page-9 crop confirms the printed spelling "Gaitonade".

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Typo Table 1, type of serodiscordancy row reads "HIV positive woman, HIV-negative woman" with no hyphen; the other rows read "HIV-positive ...".
  • p. 15 Table 1, type of serodiscordancy
    HIV positive woman, HIV-negative woman

Judge's note: On the crop image, the last row of Table 1 shows "HIV positive woman" with a space and no hyphen. The three rows above it read "HIV-positive man"/"HIV-positive woman". This is a cosmetic inconsistency.

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Typo Table 3, univariate analysis, male sex vs. female sex, linked transmission column prints "0.69 (0.31–1. 52)" with a stray space inside 1.52.
  • p. 19 Table 3, univariate, male sex, linked transmission
    0.69 (0.31–1. 52)

Judge's note: The crop image of Table 3 shows the space after the decimal point ("1. 52") in the typeset table, so it is not an extraction artefact. The other cells have no such space. This is cosmetic.

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