Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Atazanavir Sulfate; Didanosine; Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Lamivudine, zidovudine drug combination; Reverse Transcriptase Inhibitors; Tenofovir; Zidovudine

Criteria

Inclusion Criteria :>

• HIV-1 infected>

• CD4 count fewer than 300 cells/mm3 >

• Viral load test result>

• Absolute Neutrophil Count at least 750mm3 >

• Hemoglobin at least 7.5 g/dL>

• Platelet count at least 50,000/mm3>

• Calculated creatinine clearance at least 60 mL/min>

• A , A, and alkaline phosphatase <= 5 times upper limit of normal>

• total bilirubin <= 2.5 times upper limit of normal>

• Karnofsky performance score of 70 or higher>

• Plans to stay in the area for the duration of the study>

• Agrees to use acceptable forms of contraception for the duration of the study>

Exclusion Criteria:>

• More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period for the purpose of pMTCT)>

• Acute therapy for serious medical illnesses within 14 days prior to study entry>

• Certain abnormal laboratory values>

• Radiation therapy or chemotherapy within 45 days prior to study entry. >

• Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. >

• Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation>

• Inflamed pancreas within 3 years prior to study entry>

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

• Heart rate less than 40 beats/min>

• History of untreated, active second- or third-degree heart block>

• Currently detained in jail or for treatment of a psychiatric or physical illness>

• Vomiting or inability to swallow medications>

• Pregnancy>