Trial Outcomes & Findings for Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet (NCT NCT01694420)
NCT ID: NCT01694420
Last Updated: 2017-04-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
33 participants
Primary outcome timeframe
24 weeks
Results posted on
2017-04-12
Participant Flow
Participants for this study are recruited from AHI participants referred to our ID clinics. Referrals are generated from the NC STAT Program and from clinical diagnoses made by both internal and external health care clinics.
Participant milestones
| Measure |
Quad FDC
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Quad FDC
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Treatment of Acute HIV Infection With Quad Fixed-dose Combination (FDC) Tablet
Baseline characteristics by cohort
| Measure |
Quad FDC
n=33 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Quad FDC
n=30 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24
|
28 participants
|
PRIMARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Quad FDC
n=30 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48
|
24 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Quad FDC
n=30 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF
HIV RNA <200 copies/mL
|
26 days
Interval 7.0 to 132.0
|
|
Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF
HIV RNA <50 copies/mL
|
54 days
Interval 12.0 to 251.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Quad FDC
n=30 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Number of Participants With Grade 3 or Grade 4 Adverse Events
Grade 3
|
3 participants
|
|
Number of Participants With Grade 3 or Grade 4 Adverse Events
Grade 4
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Quad FDC
n=30 Participants
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Number of Participants With Adverse Events Related to Study Drug
|
22 participants
|
Adverse Events
Quad FDC
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quad FDC
n=33 participants at risk
FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks
(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33
|
|
Psychiatric disorders
Anxiety
|
3.0%
1/33
|
|
Injury, poisoning and procedural complications
Chest wall injury
|
3.0%
1/33
|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33
|
|
General disorders
Decreased appetite
|
3.0%
1/33
|
|
Nervous system disorders
Decreased comprehension
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Decreased neutrophils
|
6.1%
2/33
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
6/33
|
|
Skin and subcutaneous tissue disorders
Disseminated itching
|
3.0%
1/33
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33
|
|
General disorders
Dry mouth
|
3.0%
1/33
|
|
Hepatobiliary disorders
Elevated ALT
|
12.1%
4/33
|
|
Hepatobiliary disorders
Elevated AST
|
15.2%
5/33
|
|
Surgical and medical procedures
Elevated BP during leukapheresis
|
21.2%
7/33
|
|
Renal and urinary disorders
Elevated creatinine
|
3.0%
1/33
|
|
Hepatobiliary disorders
Elevated lipase
|
3.0%
1/33
|
|
Endocrine disorders
Elevated cholesterol
|
3.0%
1/33
|
|
General disorders
Fatigue
|
15.2%
5/33
|
|
General disorders
Feeling of air stuck in throat
|
3.0%
1/33
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33
|
|
Nervous system disorders
Headache
|
21.2%
7/33
|
|
General disorders
Hot flashes
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.1%
2/33
|
|
Endocrine disorders
Hypothyroidism
|
3.0%
1/33
|
|
Gastrointestinal disorders
Increased appetite
|
3.0%
1/33
|
|
General disorders
Alteration in taste
|
3.0%
1/33
|
|
Gastrointestinal disorders
Nausea
|
18.2%
6/33
|
|
General disorders
Night sweats
|
3.0%
1/33
|
|
Renal and urinary disorders
Proteinuria
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33
|
|
Gastrointestinal disorders
Shigella colitis
|
6.1%
2/33
|
|
Nervous system disorders
Short term memory loss
|
3.0%
1/33
|
|
Gastrointestinal disorders
stomach cramping
|
3.0%
1/33
|
|
General disorders
thigh weakness
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
thinning hair
|
3.0%
1/33
|
|
Surgical and medical procedures
Tingling around lips during leukaphersis
|
12.1%
4/33
|
|
General disorders
Weight loss
|
3.0%
1/33
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place