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Early HIV Therapy in Patients With High CD4 Cell Counts

NCT01479634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2016-03-04

No results posted yet for this study

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

Conditions

Interventions

DRUG

Standard ART

Standard Ugandan 3-drug antiretroviral therapy regimen consistent with current practices

DRUG

Study-Provided ART

Study provided drugs: 1. Truvada® (one tablet PO daily of fixed dose combination consisting of tenofovir disoproxyl fumarate \[TDF\] and emtricitabine \[FTC\]) PLUS 2. Efavirenz \[EFV\]

Sponsors & Collaborators

  • Makerere University Joint AIDS Program

    collaborator OTHER

  • Infectious Diseases Research Collaboration, Uganda

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Diane Havlir, MD · University of California, San Francisco, San Francisco, CA, USA

  • Vivek Jain, MD · University of California, San Francisco, San Francisco, CA, USA

  • Moses Kamya, MBChB, MMed, PhD · Makerere University School of Medicine, Kampala, Uganda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479634 on ClinicalTrials.gov