Table 2. Clinical endpoints and other reasons for initiating HAART.
| Reasons for initiating HAART | Prednisolone | Placebo | ||
|---|---|---|---|---|
| Clinical study endpoints | ||||
| AIDS-defining conditions | Overall | 4 | 11 | |
| Candidiasis oesophageal | 0 | 1 | ||
| Cervix carcinoma | 0 | 1 | ||
| Kaposi sarcoma | 0 | 1 | ||
| M. tuberculosis disease | 3 | 3 | ||
| Toxoplasmosis of the brain | 0 | 1 | ||
| P. jirovecii pneumonia | 1 | 1 | ||
| Pneumonia recurrent | 0 | 2 | ||
| Wasting syndrome | 0 | 1 | ||
| CD4 < 200 | 15 | 17* | ||
| Death | 0 | 0 | ||
| total reaching clinical study endpoint | 19 | 28 | ||
| Non-endpoints§§ | ||||
| CD4 < 350 and WHO stage 3§ | Overall | 5 | 2 | |
| candidiasis, oropharyngeal | 1 | 0 | ||
| cough, fever, weight loss | 1 | 0 | ||
| fever, prolonged | 0 | 1 | ||
| tonsillitis, pneumonia | 1 | 0 | ||
| other reasons# | candidiasis, oral, CD4 of 380 cells/μl | 1 | 0 | |
| asymptomatic, low CD4 count, but above 200 (203 and 201) | 1 | 1 | ||
| total receiving HAART | 24 | 30 | ||
*) one patient receiving placebo developed an AIDS-defining condition with CD4 counts < 200. In this table this patient was only listed under AIDS-defining conditions, and not also under the CD4 criterion.
§) During the study, the National Treatment guidelines in Tanzania were updated in 2009. Since then, the initiation of HAART was indicated at WHO stage 4, or at CD4 counts < 350 cells/μl if a (non-AIDS-defining) opportunistic infection (WHO stage 3) is present. Due to difficulties in drug supply this update was fully implemented at out study site only since 2011. A total of 4 study participants fulfilled this condition and discontinued participation in the study and received HAART.
#) In one case the decision to initiate HAART was not in accordance with the study protocol or the national guidelines, but was done at the discretion of the treating clinician. Before initiation of HAART at study month 4, and with a CD4 count of 380 cells/μl and a non-AIDS-defining condition (oral candidiasis), the patient presented with stable CD4 counts of 723 cells/μl (baseline), 754 cells/μl (month 1), 524 cells/μl (month 2), and 812 cells/μl (at month 3). CD4 counts continued to be stable immediately after initiation of HAART (486 cells/μl at week 6 and 714 cells/μl at week 10). In two cases, HAART was initiated in asymptomatic infection at 203 (prednisolone) and 201 (placebo) cells/μl.
§§) These study participants were censored in the Kaplan-Meyer analysis.