Major Depression Clinical Trials

• Documented HIV-1 infection.

• Diagnosis of MDD.

• On current ART regimen for at least 90 days prior to study entry with no interruption in treatment greater than 7 consecutive days.

• No plans to change ART while on study.

• Plasma HIV-1 RNA levels of less than 200 copies/mL obtained within 90 days prior to enrollment.

• Study candidates previously treated for depression are eligible provided the study candidate's last dose of antidepressant taken is at least 4 weeks prior to study entry, with the exception of fluoxetine, which the last dose taken must have been at least 8 weeks prior to study entry.

• Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record.

• Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry.

• Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception.

• Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP.

• Laboratory values that meet LP protocol criteria as determined by the site investigator.

• No history of a positive syphilis testing per local testing algorithms or clinical documentation of prior syphilis treatment.