Trial Outcomes & Findings for Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01) (NCT NCT00525733)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

48 weeks

Results posted on

2015-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	3-drug Standard Therapy FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)	5-drug Experimental Therapy FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food) Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food) Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)
Overall Study STARTED	14	26
Overall Study COMPLETED	11	23
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	3-drug Standard Therapy n=11 Participants FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)	5-drug Experimental Therapy n=23 Participants FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food) Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food) Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)	Total n=34 Participants Total of all reporting groups
Age, Continuous	37 years n=5 Participants	41 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	23 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	23 participants n=7 Participants	34 participants n=5 Participants
Mean log baseline HIV-1 RNA	5.6 log copies/mL n=5 Participants	6.3 log copies/mL n=7 Participants	5.8 log copies/mL n=5 Participants
Mean CD4+ T-cell count	539 cells/mm^3 n=5 Participants	405 cells/mm^3 n=7 Participants	496 cells/mm^3 n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome measures
Measure	3-drug Standard Therapy n=11 Participants FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)	5-drug Experimental Therapy n=21 Participants FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food) Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food) Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food) Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)
The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.	3 # subjects without detectable viremia	9 # subjects without detectable viremia

Adverse Events

3-drug Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

5-drug Experimental Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin Markowitz MD

Aaron Diamond AIDS Research Center

Phone: 212-448-5020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place