Trial Outcomes & Findings for Co-receptor Tropism Determination of HIV-1 Subtype A Spread in the Russian Federation Using V3-based Genotyping Tools (NCT NCT01823614)

Results Overview

Recruitment status

COMPLETED

Target enrollment

943 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-03-20

Participant Flow

Enrollment of patients will be conducted during 4 months of study. Patients will be selected from the AIDS centers and the Republican Clinical Hospital for Infectious Diseases, which are participants of the study. Totally there will be 12 AIDS centers. Expected number of patients will be 70 people per participant.

Patient exclusion criteria: Pregnancy at the time of obtaining of biological material for women, patients receiving cytotoxic agents, patients receiving immunomodulatory drugs, pParticipation in clinical trials with experimental drugs, experience of using of CCR5-antagonists.

Participant milestones

Participant milestones
Measure	Naïve Patients, >500 The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3	Naïve Patients, 350-500 The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3	Naïve Patients, <350 The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3	ARVT <6 Months The group contains patients who have ARVT experience and obtain ART treatment less than 6 months	ARVT From 6 Months to 3 Years The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years	ARVT >3 Years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Overall Study STARTED	179	140	176	122	172	154
Overall Study COMPLETED	179	140	176	122	172	154
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Co-receptor Tropism Determination of HIV-1 Subtype A Spread in the Russian Federation Using V3-based Genotyping Tools

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naïve Patients, >500 n=179 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3	Naïve Patients, 350-500 n=140 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3	Naïve Patients, <350 n=176 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3	ARVT <6 Months n=122 Participants The group contains patients who have ARVT experience and obtain ART treatment less than 6 months	ARVT From 6 Months to 3 Years n=172 Participants The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years	ARVT >3 Years n=154 Participants The group contains patients who have ARVT experience and obtain ART treatment more than 3 years	Total n=943 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	33 years n=7 Participants	35 years n=5 Participants	35 years n=4 Participants	36 years n=21 Participants	37 years n=8 Participants	35 years n=8 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	79 Participants n=7 Participants	96 Participants n=5 Participants	61 Participants n=4 Participants	95 Participants n=21 Participants	73 Participants n=8 Participants	509 Participants n=8 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	61 Participants n=7 Participants	80 Participants n=5 Participants	61 Participants n=4 Participants	77 Participants n=21 Participants	81 Participants n=8 Participants	434 Participants n=8 Participants
Nadir CD4 cell count	664 cells/µl FULL_RANGE 50 • n=5 Participants	413 cells/µl FULL_RANGE 50 • n=7 Participants	33 cells/µl FULL_RANGE 50 • n=5 Participants	288 cells/µl FULL_RANGE 50 • n=4 Participants	350 cells/µl FULL_RANGE 50 • n=21 Participants	394 cells/µl FULL_RANGE 50 • n=8 Participants	380 cells/µl FULL_RANGE 50 • n=8 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Naïve Patients, >500 n=161 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3	Naïve Patients, 350-500 n=116 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3	Naïve Patients, <350 n=159 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3	ARVT <6 Months n=110 Participants The group contains patients who have ARVT experience and obtain ART treatment less than 6 months	ARVT From 6 Months to 3 Years n=141 Participants The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years	ARVT >3 Years n=126 Participants The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia R5-tropic	123 participants	85 participants	114 participants	78 participants	86 participants	82 participants
Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia X4-tropic	38 participants	31 participants	45 participants	32 participants	55 participants	44 participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Naïve Patients, >500 n=243 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3	Naïve Patients, 350-500 n=216 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3	Naïve Patients, <350 n=364 Participants The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3	ARVT <6 Months The group contains patients who have ARVT experience and obtain ART treatment less than 6 months	ARVT From 6 Months to 3 Years The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years	ARVT >3 Years The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count R5-tropic	179 participants	160 participants	239 participants	—	—	—
Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count X4-tropic	64 participants	56 participants	125 participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks