Status:
COMPLETED
A Prospective, Open-label Trial of Two ABC/3TC Based Regimens in Late Presenter naïve Patients (CD4 <200 Cells/µL)
Lead Sponsor:
University of Modena and Reggio Emilia
Conditions:
HIV Infection
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
1\. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to compare the 48-weeks virological response of two different regimens containing abacavir/lamivudine (abacavir/...
Detailed Description
1\. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to compare the 48-weeks virological response of two different regimens containing abacavir/lamivudine (abacavir/...
Eligibility Criteria
Inclusion
- Males or females (inpatients or outpatients) aged 18-64 years who are HIV-1 antibody seropositive, with a CD4 count \<200 cells/uL.
- All patients should be antiretroviral-naive
- All patients should be HLA B57 or HLA B5701 negative
- Patients must have an HIV RNA level \<500,000 copies/mL
- Patients with an active opportunistic infection could be enrolled as long as this was diagnosed more than 2 weeks prior to screening.
- Patients must meet the following laboratory criteria. Neutrophil count \> 1,000 cells/mm3 Haemoglobin \> 9.0 grams/dl (men and women) Platelet count ≥ 75,000 cells/mm3 Alkaline phosphatase \< 3.0 the upper limit of normal ALT and AST \< 3.9 times the upper limit of normal Total bilirubin \< 1.5 times the upper limit of normal.
- Female patients of childbearing potential must be willing to use a reliable form of contraception, which will include a medically approved form of barrier contraception.
- Patients must be able to provide written consent to comply with study requirements.
Exclusion
- Patients with genotypic mutations for any of the study drugs.
- Patients with an opportunistic infection diagnosed in the 2 weeks prior to screening.
- Female patients who are pregnant or breastfeeding.
- Patients who are receiving any investigational drug or anti-neoplastic radiotherapy/chemotherapy other than local skin radiotherapy within 12 weeks before randomization.
- Patients with a current history of intravenous drug abuse, alcohol or substance abuse.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01900106
Start Date
November 1 2013
End Date
December 1 2017
Last Update
April 23 2019
Active Locations (1)
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1
University of Modena and Reggio Emilia
Modena, Italy, 41124