Status:
COMPLETED
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
In developed countries, standard effective antiretroviral (ARV) therapy for treatment-naive HIV infected people includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRT...
Eligibility Criteria
Inclusion
- 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\>
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1571 Patients enrolled
Trial Details
Trial ID
NCT00084136
Start Date
May 1 2005
End Date
May 1 2010
Last Update
October 10 2018
Active Locations (42)
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1
University of Southern California
Los Angeles, California, United States, 90033-1079
2
UCLA CARE Center CRS
Los Angeles, California, United States, 90095-1793
3
Harbor General/UCLA
Torrance, California, United States, 90502-2052
4
Univ. of Colorado Health Sciences Center, Denver
Denver, Colorado, United States