Trial Outcomes & Findings for Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women (NCT NCT00604175)

Last Updated: 2021-11-04

Results Overview

Percentage of participants with HPV6 antibody development from seronegative status (HPV6 antibody titers \<20 mMU/mL) at baseline to seropositive (HPV6 antibody titers \>=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

319 participants

Primary outcome timeframe

Week 28

Results posted on

2021-11-04

Participant Flow

319 HIV-infected women 13-45 years of age were recruited in US, South Africa and Brazil between March 2008 and July 2011 for participation in this study.

Participants were enrolled into 3 strata based on screening CD4 cell count: * Stratum A: CD4 cell count \>350 cells/mm\^3 * Stratum B: CD4 cell count \>200 to \<=350 cells/mm\^3 * Stratum C: CD4 cell count \<=200 cells/mm\^3

Participant milestones

Participant milestones
Measure	Stratum A Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Entry Through Week 28 STARTED	130	95	94
Entry Through Week 28 COMPLETED	120	92	93
Entry Through Week 28 NOT COMPLETED	10	3	1
Week 29 Through Week 72 STARTED	120	92	93
Week 29 Through Week 72 COMPLETED	108	85	89
Week 29 Through Week 72 NOT COMPLETED	12	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratum A Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Entry Through Week 28 Death	2	0	0
Entry Through Week 28 Withdrawal by Subject	1	0	0
Entry Through Week 28 Lost to Follow-up	4	3	0
Entry Through Week 28 Ineligible	1	0	0
Entry Through Week 28 Did not start intervention	2	0	1
Week 29 Through Week 72 Death	0	0	1
Week 29 Through Week 72 Lost to Follow-up	12	6	2
Week 29 Through Week 72 Site closure	0	1	0
Week 29 Through Week 72 Non-adherence to study requirements	0	0	1

Baseline Characteristics

Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum A n=127 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Total n=315 Participants Total of all reporting groups
Human Papillomavirus Type 16 (HPV16) Serostatus Seronegative	77 Participants n=5 Participants	65 Participants n=7 Participants	67 Participants n=5 Participants	209 Participants n=4 Participants
Human Papillomavirus Type 16 (HPV16) Serostatus Seropositive	44 Participants n=5 Participants	30 Participants n=7 Participants	26 Participants n=5 Participants	100 Participants n=4 Participants
Age, Continuous	35 years n=5 Participants	38 years n=7 Participants	36 years n=5 Participants	36 years n=4 Participants
Age, Customized 13 - 17 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized 18 - 24 years	10 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Age, Customized 25 - 29 years	24 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	47 Participants n=4 Participants
Age, Customized 30 - 34 years	26 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Customized 35 - 39 years	31 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	81 Participants n=4 Participants
Age, Customized 40 - 45 years	36 Participants n=5 Participants	41 Participants n=7 Participants	29 Participants n=5 Participants	106 Participants n=4 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	95 Participants n=7 Participants	93 Participants n=5 Participants	315 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White, Non-Hispanic	19 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized Black, Non-Hispanic	67 Participants n=5 Participants	59 Participants n=7 Participants	51 Participants n=5 Participants	177 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic (Regardless of Race)	39 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	96 Participants n=4 Participants
Race/Ethnicity, Customized Asian, Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	113 Participants n=5 Participants	80 Participants n=7 Participants	69 Participants n=5 Participants	262 Participants n=4 Participants
Region of Enrollment Brazil	11 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Region of Enrollment South Africa	3 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants
HIV Antiretroviral Therapy (ART) Status On ART	58 Participants n=5 Participants	71 Participants n=7 Participants	80 Participants n=5 Participants	209 Participants n=4 Participants
HIV Antiretroviral Therapy (ART) Status Not on ART	69 Participants n=5 Participants	24 Participants n=7 Participants	13 Participants n=5 Participants	106 Participants n=4 Participants
CD4 Cell Count	519 Cells/mm^3 n=5 Participants	287 Cells/mm^3 n=7 Participants	154 Cells/mm^3 n=5 Participants	310 Cells/mm^3 n=4 Participants
Nadir CD4 Cell Count	368 Cells/mm^3 n=5 Participants	176 Cells/mm^3 n=7 Participants	41 Cells/mm^3 n=5 Participants	179 Cells/mm^3 n=4 Participants
HIV Viral Load <=10,000 copies/mL	71 Participants n=5 Participants	69 Participants n=7 Participants	61 Participants n=5 Participants	201 Participants n=4 Participants
HIV Viral Load >10,000 copies/mL	56 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	113 Participants n=4 Participants
HIV Viral Load Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Human Papillomavirus Type 6 (HPV6) Serostatus Seronegative	66 Participants n=5 Participants	60 Participants n=7 Participants	56 Participants n=5 Participants	182 Participants n=4 Participants
Human Papillomavirus Type 6 (HPV6) Serostatus Seropositive	54 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	126 Participants n=4 Participants
Human Papillomavirus Type 6 (HPV6) Serostatus Unknown	7 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Human Papillomavirus Type 11 (HPV11) Serostatus Seronegative	99 Participants n=5 Participants	72 Participants n=7 Participants	74 Participants n=5 Participants	245 Participants n=4 Participants
Human Papillomavirus Type 11 (HPV11) Serostatus Seropositive	22 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	64 Participants n=4 Participants
Human Papillomavirus Type 11 (HPV11) Serostatus Unknown	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Human Papillomavirus Type 16 (HPV16) Serostatus Unknown	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Human Papillomavirus Type 18 (HPV18) Serostatus Seronegative	92 Participants n=5 Participants	83 Participants n=7 Participants	73 Participants n=5 Participants	248 Participants n=4 Participants
Human Papillomavirus Type 18 (HPV18) Serostatus Seropositive	29 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants	61 Participants n=4 Participants
Human Papillomavirus Type 18 (HPV18) Serostatus Unknown	6 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 28

Population: Per-protocol analysis including all participants seronegative to HPV6 at baseline who completed the vaccination series per protocol and had HPV6 titer available at Week 28.

Outcome measures

Outcome measures
Measure	Stratum A n=54 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=50 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=45 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Percentage of Participants With HPV6 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series	96.3 Percentage of participants Interval 87.3 to 99.5	100.0 Percentage of participants Interval 92.9 to 100.0	84.4 Percentage of participants Interval 70.5 to 93.5

PRIMARY outcome

Timeframe: Week 28

Population: Per-protocol analysis including all participants seronegative to HPV11 at baseline who completed the vaccination series per protocol and had HPV11 titer available at Week 28.

Percentage of participants with HPV11 antibody development from seronegative status (HPV11 antibody titers \<16 mMU/mL) at baseline to seropositive (HPV11 antibody titers \>=16 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

Outcome measures

Outcome measures
Measure	Stratum A n=86 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=59 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=62 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Percentage of Participants With HPV11 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series	97.7 Percentage of participants Interval 91.9 to 99.7	98.3 Percentage of participants Interval 90.9 to 100.0	91.9 Percentage of participants Interval 82.2 to 97.3

PRIMARY outcome

Timeframe: Week 28

Population: Per-protocol analysis including all participants seronegative to HPV16 at baseline who completed the vaccination series per protocol and had HPV16 titer available at Week 28.

Percentage of participants with HPV16 antibody development from seronegative status (HPV16 antibody titers \<20 mMU/mL) at baseline to seropositive (HPV16 antibody titers \>=20 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

Outcome measures

Outcome measures
Measure	Stratum A n=67 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=56 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=56 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Percentage of Participants With HPV16 Antibody Development From Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series	98.5 Percentage of participants Interval 92.0 to 100.0	98.2 Percentage of participants Interval 90.4 to 100.0	92.9 Percentage of participants Interval 82.7 to 98.0

PRIMARY outcome

Timeframe: Week 28

Population: Per-protocol analysis including all participants seronegative to HPV18 at baseline who completed the vaccination series per protocol and had HPV18 titer available at Week 28.

Percentage of participants with HPV18 antibody development from seronegative status (HPV18 antibody titers \<24 mMU/mL) at baseline to seropositive (HPV18 antibody titers \>=24 mMU/mL) status a month after the completion of HPV vaccination series. HPV serotyping was performed centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum.

Outcome measures

Outcome measures
Measure	Stratum A n=78 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=71 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=61 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Percentage of Participants With HPV18 Antibody Development From the Seronegative Status at Baseline to Seropositive Status a Month After Completion of HPV Vaccination Series	91.0 Percentage of participants Interval 82.4 to 96.3	84.5 Percentage of participants Interval 74.0 to 92.0	75.4 Percentage of participants Interval 62.7 to 85.5

SECONDARY outcome

Timeframe: Weeks 28, 72

Population: All eligible participants who received at least one vaccine and were seronegative for HPV6 (HPV6-) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=60; 58; 52. Week 72: n=55; 53; 53.

HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6). Geometric mean HPV6 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV6 (\<20 mMU/mL) at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=66 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=60 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=56 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline HPV6 titers at Week 28 (n=60; 58; 52)	462.3 mMU/mL Interval 320.5 to 666.8	349.2 mMU/mL Interval 242.1 to 503.8	137.1 mMU/mL Interval 82.0 to 229.1
HPV6 Antibody Titers Among Those Seronegative for HPV6 at Baseline HPV6 titers at Week 72 (n=55; 53; 53)	112.8 mMU/mL Interval 81.5 to 155.9	79.9 mMU/mL Interval 52.1 to 122.6	43.0 mMU/mL Interval 29.0 to 63.7

SECONDARY outcome

Timeframe: Weeks 28, 72

Population: All eligible participants who received at least one vaccine and were seronegative for HPV11 (HPV11-) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=93; 70; 71. Week 72: n=83; 66; 69.

HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11). Geometric mean HPV11 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV11 (\<16 mMU/mL) at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=99 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=72 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=74 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline HPV11 at Week 72 (n=83; 66; 69)	122.3 mMU/mL Interval 90.1 to 166.0	85.1 mMU/mL Interval 56.0 to 129.3	52.9 mMU/mL Interval 35.0 to 79.9
HPV11 Antibody Titers Among Those Seronegative for HPV11 at Baseline HPV11 at Week 28 (n=93; 70; 71)	476.5 mMU/mL Interval 361.8 to 627.5	417.2 mMU/mL Interval 286.8 to 606.8	205.1 mMU/mL Interval 128.7 to 326.9

SECONDARY outcome

Timeframe: Weeks 28, 72

Population: All eligible participants who received at least one vaccine and were seronegative for HPV16 (HPV16-) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=73; 63; 64. Week 72: n=63; 59; 64.

HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16). Geometric mean HPV16 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV16 (\<20 mMU/mL) at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=77 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=65 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=67 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline HPV16 at Week 28 (n=73; 63; 64)	1199.9 mMU/mL Interval 870.5 to 1654.1	1117.1 mMU/mL Interval 746.2 to 1672.4	570.8 mMU/mL Interval 327.7 to 994.3
HPV16 Antibody Titers Among Those Seronegative for HPV16 at Baseline HPV16 at Week 72 (n=63; 59; 64)	248.9 mMU/mL Interval 171.3 to 361.6	170.4 mMU/mL Interval 106.8 to 271.8	98.3 mMU/mL Interval 61.9 to 156.1

SECONDARY outcome

Timeframe: Weeks 28, 72

Population: All eligible participants who received at least one vaccine and were seronegative for HPV18 (HPV18-) at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=86; 80; 69. Week 72: n=75; 73; 69.

HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18). Geometric mean HPV18 titers with 95% CIs were calculated among the subset of participants who were seronegative for HPV18 (\<24 mMU/mL) at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=92 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=83 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=73 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline HPV18 at Week 28 (n=86; 80; 69)	175.0 mMU/mL Interval 126.2 to 242.6	170.8 mMU/mL Interval 114.5 to 254.7	93.6 mMU/mL Interval 58.6 to 149.4
HPV18 Antibody Titers Among Those Seronegative for HPV18 at Baseline HPV18 at Week 72 (n=75; 73; 69)	41.9 mMU/mL Interval 29.5 to 59.0	40.6 mMU/mL Interval 27.0 to 61.2	20.8 mMU/mL Interval 14.5 to 30.0

SECONDARY outcome

Timeframe: Weeks 0, 28, 72

Population: All eligible participants who received at least one vaccine and were seropositive for HPV6 (HPV6+) at baseline (the number of participants analyzed) and had HPV6 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=52; n=33; n=36. Week 72: n=43; 31; 35.

Change in log10 HPV6 antibody titers was calculated as log10 HPV6 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV6 antibody titers at baseline among those seropositive for HPV6 (\>=20 mMU/mL) at baseline. HPV antibody titers to type 6 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (7 mMU/mL, and after assay change in December 2012, 11 mMU/mL for HPV6).

Outcome measures

Outcome measures
Measure	Stratum A n=54 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=35 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=37 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline Change in HPV6 at Week 28 (n=52; 33; 36)	1.12 Log10 mMU/mL Interval 0.59 to 1.54	1.10 Log10 mMU/mL Interval 0.61 to 1.52	0.97 Log10 mMU/mL Interval 0.55 to 1.29
Change in Log10 HPV6 Antibody Titers From Baseline Among Those Seropositive for HPV6 at Baseline Change in HPV6 at Week 72 (n=43; 31; 35)	0.73 Log10 mMU/mL Interval 0.33 to 1.14	0.70 Log10 mMU/mL Interval 0.41 to 1.0	0.44 Log10 mMU/mL Interval 0.08 to 0.82

SECONDARY outcome

Timeframe: Weeks 0, 28, 72

Population: All eligible participants who received at least one vaccine and were seropositive for HPV11 (HPV11+) at baseline (the number of participants analyzed) and had HPV11 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=20; 21; 17. Week 72: n=17; 18; 19.

Change in log10 HPV11 antibody titers was calculated as log10 HPV11 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV11 antibody titers at baseline among those seropositive for HPV11 (\>=16 mMU/mL) at baseline. HPV antibody titers to type 11 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (8 mMU/mL for HPV11).

Outcome measures

Outcome measures
Measure	Stratum A n=22 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=23 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=19 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline Change in HPV11 at Week 28 (n=20; 21; 17)	1.32 Log10 mMU/mL Interval 1.07 to 1.71	1.42 Log10 mMU/mL Interval 0.86 to 1.59	0.60 Log10 mMU/mL Interval 0.28 to 1.25
Change in Log10 HPV11 Antibody Titers From Baseline Among Those Seropositive for HPV11 at Baseline Change in HPV11 at Week 72 (n=17; 18; 19)	0.93 Log10 mMU/mL Interval 0.66 to 1.29	0.89 Log10 mMU/mL Interval 0.64 to 1.14	0.43 Log10 mMU/mL Interval 0.01 to 0.79

SECONDARY outcome

Timeframe: Weeks 0, 28, 72

Population: All eligible participants who received at least one vaccine and were seropositive for HPV16 (HPV16+) at baseline (the number of participants analyzed) and had HPV16 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=40; 28; 24. Week 72: n=37; 25; 24.

Change in log10 HPV16 antibody titers was calculated as log10 HPV16 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV16 antibody titers at baseline among those seropositive for HPV16 (\>=20 mMU/mL) at baseline. HPV antibody titers to type 16 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (11 mMU/mL for HPV16).

Outcome measures

Outcome measures
Measure	Stratum A n=44 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=30 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=26 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline Change in HPV16 at Week 28 (n=40; 28; 24)	1.65 Log10 mMU/mL Interval 1.26 to 1.93	1.29 Log10 mMU/mL Interval 0.84 to 1.86	1.06 Log10 mMU/mL Interval 0.62 to 1.79
Change in Log10 HPV16 Antibody Titers From Baseline Among Those Seropositive for HPV16 at Baseline Change in HPV16 at Week 72 (n=37; 25; 24)	1.28 Log10 mMU/mL Interval 0.79 to 1.68	0.97 Log10 mMU/mL Interval 0.56 to 1.59	0.53 Log10 mMU/mL Interval 0.17 to 1.04

SECONDARY outcome

Timeframe: Weeks 0, 28, 72

Population: All eligible participants who received at least one vaccine and were seropositive for HPV18 at baseline (the number of participants analyzed) and had HPV18 titer available at the respective follow-up week. Strata A; B; C. Week 28: n=27; 11; 19. Week 72: n=25; 11; 19.

Change in log10 HPV18 antibody titers was calculated as log10 HPV18 antibody titers at a later timepoint (Week 28, Week 72) minus log10 HPV18 antibody titers at baseline among those seropositive for HPV18 (\>=24 mMU/mL) at baseline. HPV antibody titers to type 18 were measured centrally using the competitive Luminex ImmunoAssay (HPV-4, cLIA) on stored serum. The results below the lower limit of detection (LLD) were assigned the values of half the LLD (10 mMU/mL for HPV18).

Outcome measures

Outcome measures
Measure	Stratum A n=29 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=12 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=20 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline Change in HPV18 at Week 28 (n=27; 11; 19)	1.02 Log10 mMU/mL Interval 0.48 to 1.51	0.89 Log10 mMU/mL Interval 0.5 to 1.53	0.85 Log10 mMU/mL Interval 0.04 to 1.22
Change in Log10 HPV18 Antibody Titers From Baseline Among Those Seropositive for HPV18 at Baseline Change in HPV18 at Week 72 (n=25; 11; 19)	0.57 Log10 mMU/mL Interval 0.17 to 0.85	0.20 Log10 mMU/mL Interval -0.08 to 0.96	0.14 Log10 mMU/mL Interval 0.02 to 0.61

SECONDARY outcome

Timeframe: From baseline to up to Week 72

Population: All eligible participants who received at least one vaccine.

Number of participants who experienced a sign or symptom of Grade 3 or higher at any time after baseline while on study. Grading of signs and symptoms was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Outcome measures

Outcome measures
Measure	Stratum A n=127 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Number of Participants With Signs and Symptoms of Grade 3 or Higher	20 Participants	20 Participants	16 Participants

SECONDARY outcome

Timeframe: From baseline to up to Week 72

Population: All eligible participants who received at least one vaccine.

Number of participants who experienced a laboratory abnormality of Grade 3 or higher at any time after baseline while on study. Grading of laboratory abnormalities was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.

Outcome measures

Outcome measures
Measure	Stratum A n=127 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Number of Participants With Laboratory Abnormalities of Grade 3 or Higher	10 Participants	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Weeks 0, 4, 12, 28, 52, and 72

Population: N=315 eligible participants who initiated intervention and had HIV VL available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=123; 89; 88. Week 12: n=118; 89; 90. Week 28: n=118; 91; 87. Week 52: n=109; 85; 82. Week 72: n=105; 81; 83.

A blood sample was drawn for local testing to determine the HIV VL. Change in log10 HIV VL was calculated as log10 HIV VL at a later time point (Weeks 4, 12, 28, 52 and 72) minus log10 HIV VL at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=127 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in Log10 HIV Viral Load (VL) From Baseline Change in log10 HIV VL at Week 4 (n=123; 89; 88)	0 Log10 copies/mL Interval -0.18 to 0.0	0 Log10 copies/mL Interval -0.06 to 0.11	0 Log10 copies/mL Interval -0.15 to 0.01
Change in Log10 HIV Viral Load (VL) From Baseline Change in log10 HIV VL at Week 12 (n=118; 89; 90)	0 Log10 copies/mL Interval -0.27 to 0.0	0 Log10 copies/mL Interval -0.21 to 0.09	0 Log10 copies/mL Interval -0.45 to 0.23
Change in Log10 HIV Viral Load (VL) From Baseline Change in log10 HIV VL at Week 28 (n=118; 91; 87)	0 Log10 copies/mL Interval -0.43 to 0.0	0 Log10 copies/mL Interval -0.63 to 0.12	0 Log10 copies/mL Interval -0.46 to 0.17
Change in Log10 HIV Viral Load (VL) From Baseline Change in log10 HIV VL at Week 52 (n=109; 85; 82)	0 Log10 copies/mL Interval -0.53 to 0.08	0 Log10 copies/mL Interval -1.11 to 0.0	0 Log10 copies/mL Interval -1.28 to 0.44
Change in Log10 HIV Viral Load (VL) From Baseline Change in log10 HIV VL at Week 72 (n=105; 81; 83)	0 Log10 copies/mL Interval -0.59 to 0.0	0 Log10 copies/mL Interval -1.03 to 0.0	0 Log10 copies/mL Interval -1.93 to 0.15

SECONDARY outcome

Timeframe: Weeks 0, 4, 8, 12, 24, 28, 52 and 72

Population: N=315 eligible participants who initiated intervention and had data available at Week 0 and the respective follow-up week. Strata A; B; C. Week 4: n=122; 92; 88. Week 8: n=119; 92; 90. Week 12: n=115; 87; 90. Week 24: n=117; 85; 88. Week 28: n=114; 89; 87. Week 52: n=108; 85; 87. Week 72: 105; 85; 88.

A blood sample was drawn for local testing to determine the CD4 cell count. Change in CD4 cell count was calculated as CD4 cell count at a later time point (Weeks 4, 8, 12, 24, 28, 52 and 72) minus CD4 cell count at baseline.

Outcome measures

Outcome measures
Measure	Stratum A n=127 Participants Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 Participants Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 Participants Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 4 (n=122; 92; 88)	31 Cells/mm^3 Interval -52.0 to 94.0	-3 Cells/mm^3 Interval -45.0 to 29.0	5 Cells/mm^3 Interval -13.0 to 29.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 8 (n=119; 92; 90)	21 Cells/mm^3 Interval -66.0 to 118.0	-8 Cells/mm^3 Interval -59.0 to 58.0	13 Cells/mm^3 Interval -15.0 to 44.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 12 (n=115; 87; 90)	5 Cells/mm^3 Interval -99.0 to 104.0	-3 Cells/mm^3 Interval -42.0 to 63.0	13 Cells/mm^3 Interval -19.0 to 47.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 24 (n=117; 85; 88)	12 Cells/mm^3 Interval -66.0 to 92.0	27 Cells/mm^3 Interval -50.0 to 77.0	12 Cells/mm^3 Interval -31.0 to 71.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 28 (n=114; 89; 87)	35 Cells/mm^3 Interval -60.0 to 113.0	37 Cells/mm^3 Interval -49.0 to 104.0	17 Cells/mm^3 Interval -25.0 to 72.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 52 (n=108; 85; 87)	6 Cells/mm^3 Interval -119.0 to 117.0	49 Cells/mm^3 Interval -32.0 to 151.0	40 Cells/mm^3 Interval -28.0 to 113.0
Change in CD4 Cell Count From Baseline Change in CD4 count at Week 72 (n=105; 85; 88)	31 Cells/mm^3 Interval -91.0 to 93.0	65 Cells/mm^3 Interval 6.0 to 146.0	46 Cells/mm^3 Interval -26.0 to 133.0

Adverse Events

Stratum A

Serious events: 6 serious events

Other events: 96 other events

Deaths: 0 deaths

Stratum B

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

Stratum C

Serious events: 6 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stratum A n=127 participants at risk Participants with screening CD4 count \>350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum B n=95 participants at risk Participants with screening CD4 count \>200 to \<=350 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.	Stratum C n=93 participants at risk Participants with screening CD4 count \<=200 cells/mm\^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
Blood and lymphatic system disorders Neutropenia	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Gastrointestinal disorders Acute abdomen	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
General disorders Chest pain	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
General disorders Multi-organ failure	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Infections and infestations Infection	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Infections and infestations Lobar pneumonia	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Infections and infestations Pneumonia	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	2.2% 2/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Injury, poisoning and procedural complications Brain herniation	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Investigations Liver function test abnormal	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Nervous system disorders Migraine	0.00% 0/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	1.1% 1/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.79% 1/127 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/95 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.	0.00% 0/93 • From baseline to up to Week 72 The protocol required reporting of signs and symptoms and laboratory abnormalities of \>=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.

Other adverse events

Additional Information

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ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301)-628-3313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER