Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
Information source: University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute HIV Infection; HIV Infections
Intervention: Atripla (Drug)
Phase: Phase 4
Sponsored by: University of North Carolina, Chapel Hill
Official(s) and/or principal investigator(s):
Cynthia Gay, MD, MPH, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill
JoAnn Kuruc, Phone: 919-966-8533, Email: email@example.com
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
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the safety and tolerability, and the virologic and immunologic efficacy of FTC/TDF, and efavirenz or the fixed-dose combination of efavirenz/FTC/TDF (Atripla) given once daily to patients with acute HIV infection.
To assess 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 (cerebrospinal fluid, semen, and vaginal secretions).
To define the prevalence of genotypic and phenotypic resistance to antiretroviral agents among persons diagnosed with acute HIV infection in the Southeastern United States.
Hypothesis: Once daily HAART with FTC/TDF (FDC, Truvada) + EFV administered as a single
dose pill called Atripla will reduce viral replication to <400 copies RNA/ml plasma in blood
and other body compartments in patients with acute HIV infection, reducing infectivity, and
permitting generation of HIV-specific immune responses. The treatment regimen will be well
tolerated and any lipid profile changes will be modest 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: Multi-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 the first year with continued
follow-up for an additional year pending developments on treatment cessation approaches for
patients with suppressed virus and effective immune responses.
Minimum age: 18 Years.
Maximum age: N/A.
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
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
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;
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
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
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
17. Therapy with agents with significant systemic neurotoxic, pancreatotoxic, 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.
Locations and Contacts
JoAnn Kuruc, Phone: 919-966-8533, Email: firstname.lastname@example.org
The University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Cynthia Gay, MD, MPH, Principal Investigator
Duke University, Durham, North Carolina 27707, United States; Recruiting
Charles Hicks, MD, Principal Investigator
IAS Conference Abstract-Efficacy of NNRTI-based antiretroviral therapy initiated during acute HIV infection
Starting date: January 2005
Last updated: May 20, 2011