Status:
COMPLETED
Early HIV Therapy in Patients With High CD4 Cell Counts
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Makerere University Joint AIDS Program
Infectious Diseases Research Collaboration, Uganda
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A study of antiretroviral therapy (ART) initiation under a "streamlined model of care" in HIV-positive patients with CD4+ cell counts greater ≥ 250 cells/uL
Detailed Description
After dramatic progress in recent years, HIV care for patients in resource limited settings is rapidly evolving to newer models of care delivery. Governments, non-governmental organizations and charit...
Eligibility Criteria
Inclusion
- HIV-1 infection diagnosed by a rapid HIV test or any licensed ELISA test kit and documented in the participant's medical chart and re-verified at the time of study screening (hereafter: "screen date").
- Most recent CD4+ cell count ≥ 250 cells/uL:
- Arm A: CD4+ cell count 250-350 cells/uL Arm B: CD4+ cell count \>350 cells/uL
- Age ≥ 18 years.
- Residence within a 30 kilometer radius of the Bwizibwera HC-IV.
- Willing to initiate ART if the CD4+ cell count is ≥ 350 cells/uL.
- The following laboratory values obtained at the screening visit:
- Absolute neutrophil count (ANC) ≥ 500 cells/uL
- Hemoglobin ≥ 7.0 g/dL
- Platelet count ≥ 50,000/uL
- ALT (SGPT) ≤ 5 times greater than the upper limit of normal
- Estimated glomerular filtration rate (eGFR) of ≥ 60 mL/minute by the Modification of Diet in Renal Disease (MDRD) formula:
- eGFR = 186 \* Serum creatinine-1.154 \* Age-0.203 \* \[1.21 if African\] \* \[0.742 if female\]
- Ability to swallow oral medications.
- Ability and willingness of participant to give informed written consent.
Exclusion
- Receipt at any time prior to study entry of \> 7 days cumulative treatment with any ARV or combination of ARVs, except ARVs taken for any length of time during pregnancy for the prevention of mother to child transmission (pMTCT) or ARVs taken for occupational exposure.
- For Arm B participants only: allergy/sensitivity to TDF, FTC, EFV, RTV, LPV or formulations of any of these three medications, or to co-formulated Truvada®.
- Active World Health Organization (WHO) HIV stage 3 or 4 illness
- Pregnancy.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT01479634
Start Date
October 1 2011
End Date
June 1 2015
Last Update
March 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bwizibwera Level IV Health Center
Bwizibwera, Mbarara district, Uganda