Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Reverse Transcriptase Inhibitors; Zidovudine

Criteria

Inclusion Criteria:

• HIV-infected

• Received pre- and post-test counseling at the GHESKIO Centers

• CD4 count between 200 and 350 cells/mm3

• World Health Organization (WHO) Stage I, II, or III HIV disease

• Willing to use acceptable forms of contraception

Exclusion Criteria:

• WHO Stage IV HIV disease (AIDS)

• 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry

• Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.

• Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.

• Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.

• Requires ART in the next 3 months, in the opinion of the investigator

• Other serious medical illness requiring chronic maintenance therapy (e.g., hypertension, diabetes) UNLESS the individual has completed at least 14 days of therapy prior to study enrollment AND is clinically stable

• Any psychological condition (e.g., severe depression, schizophrenia) that, in the opinion of the investigator, may interfere with the study

• Any social condition (e.g., pending emigration, pending incarceration) that, in the opinion of the investigator, may interfere with the study

• Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study

• Current inflammation of the pancreas

• Allergy/sensitivity to any of study drugs or their formulations

• Requires certain medications

• Enrolled in another therapeutic or interventional clinical trial

• Pregnant or breastfeeding