Early HIV Therapy in Patients With High CD4 Cell Counts

NCT01479634 | Completed

• 1 other identifier: EARLI
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Keywords

HIV; ART

Outcome Measures

Primary Outcomes (2)

• 48-Week Efficacy

  Proportion of patients with virologic suppression (HIV-1 plasma RNA ≤400 copies/cc) at 48 weeks, stratified by study arm.

  When all participants reach 48 weeks on study

• Programmatic Costs

  Total estimated costs of provider time, medications, diagnostic testing, and healthcare facility infrastructure per patient treated with ART for one year, stratified by study arm

  When all participants reach 48 weeks on study

Secondary Outcomes (4)

• 96-Week and 144-Week Efficacy

  When all particiants reach 96 and 144 weeks on study, respectively

• Predictors of Retention in Care

  When all participants reach 48 weeks on study, then again 144 weeks on study

• Adverse Event Rates

  When all participants reach 48 weeks on study, then again at 144 weeks

• Medication Adherence

  When all participants reach 48 weeks on study

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Treatment for HIV in participants with CD4+ cell counts 250-350 cells/uL

Drug: Standard ART

Arm B

ACTIVE COMPARATOR

Treatment for HIV in participants with CD4+ cell counts \>350 cells/uL

Drug: Study-Provided ART

Interventions

Standard ART DRUG

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

Arm A

Study-Provided ART DRUG

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 \[EFV\]

Also known as: 1) FTC/TDF, 2) Sustiva®

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University Joint AIDS Program: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Makerere University: collaborator

Study Sites (1)

Bwizibwera Level IV Health Center

Bwizibwera, Mbarara district, Uganda

Location

Related Publications (2)

• Jain V, Byonanebye DM, Amanyire G, Kwarisiima D, Black D, Kabami J, Chamie G, Clark TD, Rooney JF, Charlebois ED, Kamya MR, Havlir DV; SEARCH Collaboration. Successful antiretroviral therapy delivery and retention in care among asymptomatic individuals with high CD4+ T-cell counts above 350 cells/mul in rural Uganda. AIDS. 2014 Sep 24;28(15):2241-9. doi: 10.1097/QAD.0000000000000401.

  PMID: 25022596 RESULT

• Jain V, Chang W, Byonanebye DM, Owaraganise A, Twinomuhwezi E, Amanyire G, Black D, Marseille E, Kamya MR, Havlir DV, Kahn JG. Estimated Costs for Delivery of HIV Antiretroviral Therapy to Individuals with CD4+ T-Cell Counts >350 cells/uL in Rural Uganda. PLoS One. 2015 Dec 3;10(12):e0143433. doi: 10.1371/journal.pone.0143433. eCollection 2015.

  PMID: 26632823 DERIVED

Related Links

• MU-UCSF Research Collaboration website

MeSH Terms

Interventions

efavirenz

Study Officials

• Diane Havlir, MD

  University of California, San Francisco, San Francisco, CA, USA

  STUDY CHAIR

• Vivek Jain, MD

  University of California, San Francisco, San Francisco, CA, USA

  PRINCIPAL INVESTIGATOR

• Moses Kamya, MBChB, MMed, PhD

  Makerere University School of Medicine, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

UG (1)