Trial Outcomes & Findings for Anti-HIV Medications for People Recently Infected With HIV (NCT NCT00106171)

NCT ID: NCT00106171

Last Updated: 2023-09-13

Results Overview

All HAART-free time from initial infection with HIV to initiation of permanent HAART

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 113 participants
• Primary outcome timeframe: Through study completion, an average of 18 months
• Results posted on: 2023-09-13

Participant Flow

Participant milestones

Measure	Treated Arm Participants will receive HAART for 1 year Highly active antiretroviral therapy (HAART): Regimens will be assigned by investigators	Untreated Arm Participants will receive no treatment
Overall Study STARTED	57	56
Overall Study COMPLETED	37	46
Overall Study NOT COMPLETED	20	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-HIV Medications for People Recently Infected With HIV

Baseline characteristics by cohort

Measure	Immediate Treatment Arm n=57 Participants Participants will receive HAART for 1 year Highly active antiretroviral therapy (HAART): Regimens will be assigned by investigators	Deferred Treatment Arm n=56 Participants Participants will receive no treatment	Total n=113 Participants Total of all reporting groups
Age, Continuous	34.7 years n=93 Participants	32.8 years n=4 Participants	33.2 years n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	9 Participants n=4 Participants	14 Participants n=27 Participants
Sex: Female, Male Male	52 Participants n=93 Participants	47 Participants n=4 Participants	99 Participants n=27 Participants
Region of Enrollment Canada	27 Participants n=93 Participants	30 Participants n=4 Participants	57 Participants n=27 Participants
Region of Enrollment United States	30 Participants n=93 Participants	26 Participants n=4 Participants	56 Participants n=27 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 18 months

All HAART-free time from initial infection with HIV to initiation of permanent HAART

Outcome measures

Measure	Immediate Treatment Arm n=57 Participants Participants will receive HAART for 1 year Highly active antiretroviral therapy (HAART): Regimens will be assigned by investigators	Deferred Treatment Arm n=56 Participants Participants will receive no treatment
Total Treatment-free Time to Initiation of Permanent HAART	18 months Interval 2.0 to 22.0	18 months Interval 1.0 to 34.0

SECONDARY outcome

Timeframe: Throughout study completion, an average of 18 months

Number of participants with serious adverse events (grade 3 or 4 as defined by the NIH toxicity scale)

Outcome measures

Measure	Immediate Treatment Arm n=57 Participants Participants will receive HAART for 1 year Highly active antiretroviral therapy (HAART): Regimens will be assigned by investigators	Deferred Treatment Arm n=56 Participants Participants will receive no treatment
Toxicity as Assessed by the of Number of Participants With Serious Adverse Events	0 Participants	0 Participants

Adverse Events

Immediate Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Deferred Treatment Arm

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

Dr. Joseph Margolick

Johns Hopkins University

Phone: 410-955-1436

Email: jmargoli@jhsph.edu

Results disclosure agreements

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