Trial Outcomes & Findings for HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women (NCT NCT01815580)
NCT ID: NCT01815580
Last Updated: 2022-09-29
Results Overview
To quantify HIV viral load suppression (\<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was \<1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was \<1000 copies/mL etc.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
225 participants
Primary outcome timeframe
Baseline, Week 12, Week 24, Week 36, and Week 48
Results posted on
2022-09-29
Participant Flow
Participant milestones
| Measure |
Immediate ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
115
|
|
Overall Study
COMPLETED
|
98
|
100
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Immediate ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Excluded from analysis
|
5
|
4
|
Baseline Characteristics
2 participants in the Immediate arm and 1 participant in the deferred arm are missing a baseline CD4.
Baseline characteristics by cohort
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.9 Years
STANDARD_DEVIATION 7.3 • n=105 Participants
|
26.6 Years
STANDARD_DEVIATION 6.7 • n=111 Participants
|
27.2 Years
STANDARD_DEVIATION 7.0 • n=216 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=105 Participants
|
111 Participants
n=111 Participants
|
216 Participants
n=216 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Race (NIH/OMB)
More than one race
|
105 Participants
n=105 Participants
|
111 Participants
n=111 Participants
|
216 Participants
n=216 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=105 Participants
|
0 Participants
n=111 Participants
|
0 Participants
n=216 Participants
|
|
Region of Enrollment
Peru
|
105 participants
n=105 Participants
|
111 participants
n=111 Participants
|
216 participants
n=216 Participants
|
|
Baseline Viral Load
|
5.84 Log10(copies/mL)
STANDARD_DEVIATION 1.16 • n=105 Participants
|
5.78 Log10(copies/mL)
STANDARD_DEVIATION 0.96 • n=111 Participants
|
5.81 Log10(copies/mL)
STANDARD_DEVIATION 1.06 • n=216 Participants
|
|
Baseline CD4
|
430.1 CD4 T Cell count/mm^3
STANDARD_DEVIATION 207.6 • n=103 Participants • 2 participants in the Immediate arm and 1 participant in the deferred arm are missing a baseline CD4.
|
432.3 CD4 T Cell count/mm^3
STANDARD_DEVIATION 212.3 • n=110 Participants • 2 participants in the Immediate arm and 1 participant in the deferred arm are missing a baseline CD4.
|
431.2 CD4 T Cell count/mm^3
STANDARD_DEVIATION 209.6 • n=213 Participants • 2 participants in the Immediate arm and 1 participant in the deferred arm are missing a baseline CD4.
|
PRIMARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Not all participants had their viral load measured at all time points due to a missed visit or being lost to follow up.
To quantify HIV viral load suppression (\<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was \<1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was \<1000 copies/mL etc.
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Number of Participants With HIV Viral Load Suppression in Plasma
Suppressed at Baseline
|
2 Participants
|
1 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Plasma
Suppressed at week 12
|
84 Participants
|
8 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Plasma
Suppressed at week 24
|
93 Participants
|
18 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Plasma
Suppressed at week 36
|
91 Participants
|
89 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Plasma
Suppressed at week 48
|
94 Participants
|
92 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Analysis population is limited to study participants who gave both semen and plasma specimens. This was a planned subset of all participants. Not all participants had their semen viral load measured at all time points.
To quantify HIV viral load suppression (\<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=27 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=41 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Number of Participants With HIV Viral Load Suppression in Semen
Suppressed Baseline
|
4 Participants
|
7 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Semen
Suppressed week 12
|
21 Participants
|
17 Participants
|
|
Number of Participants With HIV Viral Load Suppression in Semen
Suppressed week 24
|
19 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: HIV diagnosis visitHIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=139 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=62 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Heavy drinker · Yes
|
30 Participants
|
14 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Heavy drinker · No
|
57 Participants
|
26 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Heavy drinker · Missing data
|
52 Participants
|
22 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Audit Score >=20 · Yes
|
16 Participants
|
4 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Audit Score >=20 · No
|
117 Participants
|
49 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Audit Score >=20 · Missing data
|
6 Participants
|
9 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Any illicit drug use · Yes
|
13 Participants
|
4 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Any illicit drug use · No
|
126 Participants
|
58 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Any illicit drug use · Missing data
|
0 Participants
|
0 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Sex Work · Yes
|
16 Participants
|
5 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Sex Work · No
|
123 Participants
|
56 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Sex Work · Missing data
|
0 Participants
|
1 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Met a sex partner at any venue · Yes
|
62 Participants
|
37 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Met a sex partner at any venue · No
|
77 Participants
|
25 Participants
|
|
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
Met a sex partner at any venue · Missing data
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: HIV diagnosis visitPopulation: Analysis population is limited to HIV-infected participants for whom HIV sequence data are available. Per initial protocol design, this analysis was conducted on all HIV sequences without dividing by randomization arm.
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=201 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
|
27 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: within 3 months of diagnosis of acute HIV infectionPopulation: Analysis population includes only those participants whose HIV infection was diagnosed during the acute phase, that is prior to HIV seroconversion.
To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care.
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=87 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
|
71 Participants
|
—
|
SECONDARY outcome
Timeframe: within 3 months of diagnosisPopulation: We were unable to trace potential partners because participants were unwilling or unable to identify recent partners
Partner tracing and notification
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=216 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Partner Tracing
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Number of Participants Retained in Care
Retained at Week 12
|
102 Participants
|
106 Participants
|
|
Number of Participants Retained in Care
Retained at Week 24
|
101 Participants
|
105 Participants
|
|
Number of Participants Retained in Care
Retained at Week 36
|
98 Participants
|
103 Participants
|
|
Number of Participants Retained in Care
Retained at Week 48
|
96 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 48 weeksTo determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation.
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Adherence to ART Regimen (Percentage of Pills Taken)
|
93.6 Percent of dispensed pills taken
Standard Deviation 4.7
|
91.5 Percent of dispensed pills taken
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Participants still in follow up at each time point who provided viral load measurement
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Adherence to Viral Load (VL) Procedure
VL at Baseline
|
105 Participants
|
111 Participants
|
|
Adherence to Viral Load (VL) Procedure
VL at Week 12
|
98 Participants
|
104 Participants
|
|
Adherence to Viral Load (VL) Procedure
VL at Week 24
|
95 Participants
|
104 Participants
|
|
Adherence to Viral Load (VL) Procedure
VL at week 36
|
96 Participants
|
99 Participants
|
|
Adherence to Viral Load (VL) Procedure
VL at Week 48
|
95 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Participants still in follow up at each time point who provided a CD4 measurement
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Adherence to CD4 Procedure
CD4 at Baseline
|
103 Participants
|
110 Participants
|
|
Adherence to CD4 Procedure
CD4 at Week 12
|
99 Participants
|
104 Participants
|
|
Adherence to CD4 Procedure
CD4 at Week 24
|
97 Participants
|
104 Participants
|
|
Adherence to CD4 Procedure
CD4 at Week 36
|
97 Participants
|
100 Participants
|
|
Adherence to CD4 Procedure
CD4 at Week 48
|
96 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48Population: Participants still in follow up at each time point who completed the study questionnaires
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48
Outcome measures
| Measure |
Immediate ART (Atripla or Stribild)
n=105 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 Participants
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Adherence to Questionnaires
CASI at Baseline
|
100 Participants
|
109 Participants
|
|
Adherence to Questionnaires
CASI at Week 12
|
96 Participants
|
102 Participants
|
|
Adherence to Questionnaires
CASI at Week 24
|
95 Participants
|
100 Participants
|
|
Adherence to Questionnaires
CASI at Week 36
|
92 Participants
|
99 Participants
|
|
Adherence to Questionnaires
CASI at Week 48
|
90 Participants
|
92 Participants
|
Adverse Events
Immediate ART (Atripla or Stribild)
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Deferred ART (Atripla or Stribild)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate ART (Atripla or Stribild)
n=105 participants at risk
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 participants at risk
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Investigations
Transaminases increased
|
0.95%
1/105 • Number of events 1 • 48 weeks
|
0.00%
0/111 • 48 weeks
|
|
Vascular disorders
Hypotension
|
0.95%
1/105 • Number of events 1 • 48 weeks
|
0.00%
0/111 • 48 weeks
|
|
Psychiatric disorders
Suicidal attempt
|
0.00%
0/105 • 48 weeks
|
0.90%
1/111 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Immediate ART (Atripla or Stribild)
n=105 participants at risk
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy
|
Deferred ART (Atripla or Stribild)
n=111 participants at risk
Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy
|
|---|---|---|
|
Infections and infestations
Proctitis chlamydial
|
7.6%
8/105 • Number of events 9 • 48 weeks
|
11.7%
13/111 • Number of events 16 • 48 weeks
|
|
Infections and infestations
Proctitis gonococcal
|
9.5%
10/105 • Number of events 10 • 48 weeks
|
10.8%
12/111 • Number of events 13 • 48 weeks
|
|
Infections and infestations
Syphilis
|
13.3%
14/105 • Number of events 16 • 48 weeks
|
11.7%
13/111 • Number of events 13 • 48 weeks
|
|
Infections and infestations
Genitourinary chlamydia infection
|
3.8%
4/105 • Number of events 4 • 48 weeks
|
7.2%
8/111 • Number of events 8 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
5/105 • Number of events 6 • 48 weeks
|
7.2%
8/111 • Number of events 9 • 48 weeks
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
2.9%
3/105 • Number of events 3 • 48 weeks
|
5.4%
6/111 • Number of events 6 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.95%
1/105 • Number of events 1 • 48 weeks
|
7.2%
8/111 • Number of events 8 • 48 weeks
|
|
Gastrointestinal disorders
Proctitis
|
1.9%
2/105 • Number of events 2 • 48 weeks
|
5.4%
6/111 • Number of events 7 • 48 weeks
|
|
Infections and infestations
Urethritis
|
2.9%
3/105 • Number of events 3 • 48 weeks
|
6.3%
7/111 • Number of events 8 • 48 weeks
|
|
General disorders
Hemorrhoids
|
0.00%
0/105 • 48 weeks
|
5.4%
6/111 • Number of events 6 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place