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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Gilead Sciences
Information provided by (Responsible Party):
Cynthia L Gay, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00924898
First received: June 17, 2009
Last updated: April 6, 2017
Last verified: April 2017
  Purpose

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. 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. 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. To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.

Condition Intervention Phase
Acute HIV Infection HIV Infections Drug: efavirenz, emtricitabine, and tenofovir Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis

Resource links provided by NLM:


Further study details as provided by Cynthia L Gay, MD, University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Number of Participants Without Virologic Failure at Week 24 [ Time Frame: HIV RNA level prior to or at week 24 following enrollment ]
    Number of participants with a HIV RNA level <200 copies/mL at week 24


Secondary Outcome Measures:
  • Number of Participants Without Virologic Failure at Week 48 [ Time Frame: HIV RNA level at week 48 following enrollment ]
    HIV RNA level <50 copies/mL at week 48

  • Number of Participants With HIV RNA Suppression at Week 96 [ Time Frame: HIV RNA level at 96 weeks following enrollment ]
    Number of participants wtih HIV RNA level <50 copies/mL at week 96

  • Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications [ Time Frame: At enrollment ]
    Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization

  • Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment [ Time Frame: At enrollment ]
    Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization

  • Time to HIV RNA Suppression <50 Copies/mL [ Time Frame: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96 ]
    Number of days from ART initiation to HIV RNA suppression <50 copies/mL


Enrollment: 92
Study Start Date: January 2005
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute HIV Treatment Group
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
Once daily ART with emtricitabine, tenofovir DF and efavirenz
Other Names:
  • Tenofovir disoproxil fumarate
  • Emtricitabine
  • FDC Emtricitabine 200 mg/ tenofovir 300 mg
  • Efavirenz
  • FDC Emtricitabine 200mg/Tenofovir 300mg DF/Efavirenz 600mg

Detailed Description:

Hypothesis: Once daily ART with fixed dose combination FTC/TDF/EFV will reduce viral replication to <200 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity. The treatment regimen will be well tolerated during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.

Study Design: Dual-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for 96 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of acute HIV infection as defined by protocol.
  2. 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)

  3. 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;
  4. 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);
  5. Weigh >/= 40 kg;

Exclusion Criteria:

  1. A life expectancy less than twelve months.
  2. Women who are pregnant or breastfeeding.
  3. Women with a positive pregnancy test on enrollment or prior to study drug administration.
  4. WOCBP who are unwilling or unable to use two acceptable methods to avoid pregnancy for the entire study period
  5. WOCBP using a prohibited contraceptive method
  6. Hypersensitivity to any component of the formulation of study drugs.
  7. 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.
  8. Proven or suspected acute hepatitis within 30 days prior to study entry (this excludes liver inflammation related to acute HIV infection).
  9. 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).
  10. An active AIDS-defining opportunistic infection or disease (for the purpose of this study, a CD4 count </=200 cells/mm3 in the absence of any other AIDS-defining indicator condition is not considered an AIDS-defining event. AIDS-defining events occurring during the acute HIV infection syndrome period such as Candida esophagitis will be considered on a case-by-case basis and will not be automatically considered exclusionary).
  11. Inability to communicate effectively with study personnel.
  12. 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.
  13. Incarceration; prisoner recruitment and participation are not permitted.
  14. Difficulty swallowing capsules/tablets.
  15. Prior treatment with any other experimental drug for any indication (within 30 days of initiating study treatment).
  16. Treatment with immune-modulating agents (within 30 days of initiating study treatment) such as cyclosporine and systemic corticosteroids. Routine vaccinations are allowed.
  17. Therapy with agents with significant systemic neurotoxic pancreotropic or cytotoxic potential within 3 months of study start, or the need for such therapy is expected at the time of enrollment.
  18. Therapy with nephrotoxic agents (aminoglycosides, IV amphotericin, cidofovir, IV pentamidine, cisplatin other agents with nephrotoxic potential), adefovir or probenecid. These agents must be discontinued at least 30 days prior to starting study medications. Brief course of aminoglycosides within 30 days of enrollment may be allowed after discussion with Study Chairs.
  19. Concomitant Medications:

    • The following medications are expressly prohibited during the course of the trial: Astemizole, cisapride, ergot derivatives, hydroxyurea, midazolam, thalidomide, triazolam, vincristine, zalcitabine, ribavirin, doxorubicin, Voriconazole, St. John's wort or any medications that are contraindicated for concomitant use as described in the current product information packet insert for the ARV therapies used.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924898

Locations
United States, North Carolina
The University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27707
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Bristol-Myers Squibb
Gilead Sciences
Investigators
Principal Investigator: Cynthia Gay, MD, MPH University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
C Gay, A Johnson, S McCoy, J Kuruc, K McGee, L McNeil, M Kerkau, J Sebastian, C Pilcher, D Margolis, P Leone, S Fiscus, G Ferrari, C Hicks, J Eron, The Duke-UNC Acute HIV Infection Consortium. "Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection." XVII International AIDS Conference, 2008 Abstract no. THPE0082.

Responsible Party: Cynthia L Gay, MD, Clinical Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00924898     History of Changes
Other Study ID Numbers: CID 0805 (PHI 02)
Study First Received: June 17, 2009
Results First Received: February 8, 2017
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cynthia L Gay, MD, University of North Carolina, Chapel Hill:
Acute HIV
HIV
Acute Infections
Acute Infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Efavirenz
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on July 26, 2017