Trial Outcomes & Findings for HIV Persistence and Viral Reservoirs (NCT NCT01025427)

Results Overview

The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to \< 5 copies/mL.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Controller
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Persistence and Viral Reservoirs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controller n=16 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to \< 5 copies/mL.

Outcome measures

Outcome measures
Measure	HIV Controller n=16 Participants Sixteen asymptomatic controllers were prospectively treated with open-label raltegravir and tenofovir/emtricitabine for 24 weeks. Controllers were defined by the following inclusion criteria: (1) HIV-seropositive; (2) ART untreated; and (3) plasma HIV RNA \<1,000 copies/mL for ≥12 months.
Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24	66 fold decrease in signal/cutoff ratio Interval 28.0 to 155.0

Adverse Events

Controller

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

Hiroyu Hatano

University of California, San Francisco

Phone: 415-476-4082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place