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Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT00924898•University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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. 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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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).
+10 more criteria

Locations (2)

The University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

November 1, 2013

Completion Date

December 1, 2013

Last Updated

May 16, 2017

Enrollment

ACTUAL participants

Conditions

Acute HIV InfectionHIV Infections

Interventions

efavirenz, emtricitabine, and tenofovir

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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