Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)

NCT00924898 | Completed Phase 4 Results

• 1 other identifier: CID 0805 (PHI 02)
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:

1. 1.To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC, TDF, and efavirenz given once daily to patients with acute HIV infection.
2. 2.To assess the impact of once daily therapy combined with a standardized adherence program on treatment adherence, virologic suppression, and rate of viral load decline in blood and infectious fluids (semen, cervico-vaginal secretions).
3. 3.To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

Conditions

Acute HIV Infection; HIV Infections

Keywords

Acute HIV; HIV; Acute Infections; Acute Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants Without Virologic Failure at Week 24

  Number of participants with a HIV RNA level \<200 copies/mL at week 24

  HIV RNA level prior to or at week 24 following enrollment

Secondary Outcomes (5)

• Number of Participants Without Virologic Failure at Week 48

  HIV RNA level at week 48 following enrollment

• Number of Participants With HIV RNA Suppression at Week 96

  HIV RNA level at 96 weeks following enrollment

• Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications

  At enrollment

• Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment

  At enrollment

• Time to HIV RNA Suppression <50 Copies/mL

  Number of days from start of study treatment until HIV RNA suppression, assessed through week 96

Study Arms (1)

Acute HIV Treatment Group

EXPERIMENTAL

Single arm, open label study in which all participants received the same study treatment with efavirenz, emtricitabine, and tenofovir DF

Drug: efavirenz, emtricitabine, and tenofovir

Interventions

efavirenz, emtricitabine, and tenofovir DRUG

Once daily ART with emtricitabine, tenofovir DF and efavirenz

Also known as: Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz, FDC Emtricitabine 200mg/Tenofovir 300mg DF/Efavirenz 600mg

Acute HIV Treatment Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of acute HIV infection as defined by protocol.
• The following laboratory parameters verified within 30 days of study entry:
• Bilirubin \</= 3.0mg/dL
• ALT/AST \</= 10 X upper limit of normal
• Absolute neutrophil count (ANC) \>/= 500cells/mm3
• Platelet count \>/= 25,000 cells/mm3
• Hemoglobin \>/= 8.5g/dL for men and \>/= 8.0 g/dL for women
• Calculated creatinine clearance (Cockcroft-Gault formula) \>/= 50mL/min:
• CrCl = (140-age) x body weight (kg) (x 0.85 if female)/ Serum creatinine \[mg/dL\] x (72)
• All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of bHCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea \>/=12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level \>/=35mLU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential;
• Be willing to use two effective forms of contraception throughout study. Barrier contraception should always be used in combination with other methods of contraception (oral or other hormonal contraceptives);
• Weigh \>/= 40 kg;

You may not qualify if:

• A life expectancy less than twelve months.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• WOCBP who are unwilling or unable to use two acceptable methods to avoid pregnancy for the entire study period
• WOCBP using a prohibited contraceptive method
• Hypersensitivity to any component of the formulation of study drugs.
• A clinically important illness not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the patient at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
• Proven or suspected acute hepatitis within 30 days prior to study entry (this excludes liver inflammation related to acute HIV infection).
• Intractable diarrhea (\>/=6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry or vomiting lasting more than 4 days within one month prior to dosing (this excludes symptoms attributed to acute HIV infection).
• Inability to communicate effectively with study personnel.
• Current alcohol or recreational drug use which in the investigator's opinion interferes with the subject's ability to comply with dosing schedule and protocol evaluations or increases the risk of developing pancreatitis.
• Incarceration; prisoner recruitment and participation are not permitted.
• Difficulty swallowing capsules/tablets.
• Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).
• Treatment with immune-modulating agents (within 30 days of initiating study treatment) such as cyclosporine and systemic corticosteroids. Routine vaccinations are allowed.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Bristol-Myers Squibb: collaborator
• Gilead Sciences: collaborator

Study Sites (2)

The University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27707, United States

Location

Related Publications (2)

• Gay CL, Willis SJ, Cope AB, Kuruc JD, McGee KS, Sebastian J, Crooks AM, McKellar MS, Margolis DM, Fiscus SA, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Fixed-dose combination emtricitabine/tenofovir/efavirenz initiated during acute HIV infection; 96-week efficacy and durability. AIDS. 2016 Nov 28;30(18):2815-2822. doi: 10.1097/QAD.0000000000001255.

  PMID: 27662549 BACKGROUND

• Gay CL, Mayo AJ, Mfalila CK, Chu H, Barry AC, Kuruc JD, McGee KS, Kerkau M, Sebastian J, Fiscus SA, Margolis DM, Hicks CB, Ferrari G, Eron JJ; Duke-UNC Acute HIV Infection Consortium. Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection. AIDS. 2011 Apr 24;25(7):941-9. doi: 10.1097/QAD.0b013e3283463c07.

  PMID: 21487250 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Cynthia Gay
• Organization: The University of North Carolina

cynthia_gay@med.unc.edu

919-843-2726

Study Officials

• Cynthia Gay, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: January 1, 2005
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)