Trial Outcomes & Findings for Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805) (NCT NCT00924898)

NCT ID: NCT00924898

Last Updated: 2017-05-16

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 92 participants
• Primary outcome timeframe: HIV RNA level prior to or at week 24 following enrollment
• Results posted on: 2017-05-16

Participant Flow

Individuals with acute HIV (AHI) detected via a statewide AHI screening program in publicly funded sites and primary care sites are reported to the NC Department of Health and Human Services (DHHS). DHHS staff immediately refer acute cases to HIV care. From Jan 2005 and Dec 2011, all AHI cases referred to UNC and Duke were offered enrollment.

This was a single-arm, open-label study of emtricitabine/tenofovir/efavirenz started at enrollment. All participants received the same study treatment. Study treatment was not delayed for baseline resistance testing. Participants with transmitted baseline resistance to any drug in the regimen were followed on study on an alternative regimen.

Participant milestones

Measure	Acute HIV Infection Treatment Group This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
Overall Study STARTED	92
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Acute HIV Infection Treatment Group This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acute HIV Infection Treatment Group n=92 Participants This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	27 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	54 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	92 Participants n=5 Participants
CD4 cell count	487 cells/mm^3 n=5 Participants
HIV RNA level	614898 copies/mL n=5 Participants
Sexual risk group Female	11 Participants n=5 Participants
Sexual risk group Heterosexual Male	9 Participants n=5 Participants
Sexual risk group Men who have sex with men	72 Participants n=5 Participants
sexually transmitted diseases within 8 weeks prior to diagnosis	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Acute HIV Infection Treatment Group n=90 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Number of Participants Without Virologic Failure at Week 24	81 Participants

SECONDARY outcome

Timeframe: HIV RNA level at week 48 following enrollment

HIV RNA level <50 copies/mL at week 48

Outcome measures

Measure	Acute HIV Infection Treatment Group n=90 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Number of Participants Without Virologic Failure at Week 48	71 Participants

SECONDARY outcome

Timeframe: HIV RNA level at 96 weeks following enrollment

Number of participants wtih HIV RNA level <50 copies/mL at week 96

Outcome measures

Measure	Acute HIV Infection Treatment Group n=75 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Number of Participants With HIV RNA Suppression at Week 96	65 Participants

SECONDARY outcome

Timeframe: At enrollment

Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization

Outcome measures

Measure	Acute HIV Infection Treatment Group n=92 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications	17 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Acute HIV Infection Treatment Group n=90 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment	71 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Acute HIV Infection Treatment Group n=89 Participants Participants suppressed to \<200 copies/mL prior to or at week 24
Time to HIV RNA Suppression <50 Copies/mL	105 days Interval 14.0 to 523.0

Adverse Events

Acute HIV Infection Treatment Group

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acute HIV Infection Treatment Group n=90 participants at risk Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
Gastrointestinal disorders Abdominal Discomfort	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Abdominal Distension	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Abdominal Pain	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Abdominal Pain Upper	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Abnormal Dreams	10.0% 9/90 • Number of events 11 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Alanine Aminotransferase Increased	4.4% 4/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Anger	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Anxiety	5.6% 5/90 • Number of events 5 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Aspartate Aminotransferase Increased	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Musculoskeletal and connective tissue disorders Back Pain	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Balance Disorder	8.9% 8/90 • Number of events 8 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Blood Cholesterol Increased	3.3% 3/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Blood Triglycerides Increased	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Claustrophobia	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Metabolism and nutrition disorders Decreased Appetite	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Depressed Mood	2.2% 2/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Depression	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Diarrhoea	7.8% 7/90 • Number of events 8 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Disturbance in Attention	4.4% 4/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Dizziness	27.8% 25/90 • Number of events 30 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Dry Mouth	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Dyspepsia	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Erythema	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Euphoric Mood	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Eye disorders Eye Swelling	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders fatigue	4.4% 4/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Feeling Abnormal	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Feeling Drunk	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Feeling Jittery	4.4% 4/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Flatulence	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Vascular disorders Flushing	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Hangover	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Headache	13.3% 12/90 • Number of events 15 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Initial Insomnia	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Insomnia	13.3% 12/90 • Number of events 12 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Irritability	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Lip Swelling	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Infections and infestations Lipase Increased	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Low Density Lipoprotein Increased	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Memory Impairment	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Mood Swings	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Nausea	17.8% 16/90 • Number of events 16 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Investigations Neutrophil Count Decreased	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Night Sweats	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Obsessive Thoughts	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Poor Quality Sleep	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Injury, poisoning and procedural complications Post Lumbar Puncture Syndrome	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Pruritis	4.4% 4/90 • Number of events 4 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Pruritis Generalised	2.2% 2/90 • Number of events 2 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Rash	6.7% 6/90 • Number of events 11 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Rash Maculo-papular	2.2% 2/90 • Number of events 6 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Rash Papular	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Rash Pruritic	1.1% 1/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Psychiatric disorders Sleep Disorder	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Sluggishness	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Somnolence	10.0% 9/90 • Number of events 9 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Skin and subcutaneous tissue disorders Swelling Face	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Syncope	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Tunnel Vision	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
General disorders Unevaluable Event	3.3% 3/90 • Number of events 3 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Eye disorders Vision Blurred	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Nervous system disorders Visual Field Defect	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Eye disorders Visual Impairment	1.1% 1/90 • Number of events 1 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.
Gastrointestinal disorders Vomiting	6.7% 6/90 • Number of events 7 • Adverse events were collected for each participant over the 96 weeks of the study. Adverse events were assessed at each visit and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatrics Adverse Events.

Additional Information

Dr. Cynthia Gay

The University of North Carolina

Phone: 919-843-2726

Email: cynthia_gay@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place