Trial Outcomes & Findings for Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection (NCT NCT00885664)

NCT ID: NCT00885664

Last Updated: 2022-08-10

Results Overview

AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2022-08-10

Participant Flow

Patients were recruited from Academic HIV practice from October 2005 through March 2009.

Participant milestones

Measure	Truvada/Kaletra All participants received the same treatment. This was a single arm study.
Overall Study STARTED	60
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

Baseline characteristics by cohort

Measure	Truvada/Kaletra CD4<100 n=26 Participants Group with CD4 lymphocyte count less than 100 cell/cu mm treated with truvada/kaletra	Truvada/Kaletra CD4>/=100 n=34 Participants Group with CD4 lymphocyte count greater than or equal to 100 cell/cu mm	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	34 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years n=5 Participants	37 years n=7 Participants	39.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
Symptom Score	10 units on a scale Interval 5.0 to 17.0	8 units on a scale Interval 6.0 to 13.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Those with lower CD4 at baseline compared to those with a higher CD4 count.

Measure of physical function out of 100. Lower score means less physical capacity.

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
SF-12 Physical Capacity Score	43 units on a scale Interval 35.0 to 52.0	54 units on a scale Interval 46.0 to 55.0

SECONDARY outcome

Timeframe: 4 weeks

Population: lower CD4 count at baseline compared to higher CD4 counts

Measure of mental functioning where lower is better out of a scale of 100.

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
SF-12 Mental Capacity Score	46 score on a scale Interval 31.0 to 57.0	50 score on a scale Interval 39.0 to 54.0

SECONDARY outcome

Timeframe: 4 weeks

Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-1 Beta	0.03 pg/mL Interval 0.03 to 0.45	0.03 pg/mL Interval 0.03 to 0.03

SECONDARY outcome

Timeframe: 4 weeks

Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-4	0.07 pg/mL Interval 0.07 to 0.73	0.07 pg/mL Interval 0.07 to 1.47

SECONDARY outcome

Timeframe: 4 weeks

Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-6	4.41 pg/mL Interval 2.11 to 8.46	4.01 pg/mL Interval 1.94 to 17.43

SECONDARY outcome

Timeframe: 4 weeks

Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-7	17.50 pg/mL Interval 12.36 to 24.3	10.53 pg/mL Interval 6.98 to 16.84

SECONDARY outcome

Timeframe: 4 weeks

Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-8	7.58 pg/mL Interval 5.83 to 9.83	5.18 pg/mL Interval 4.22 to 7.06

SECONDARY outcome

Timeframe: 4 weeks

Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
IL-10	21.32 pg/mL Interval 11.44 to 43.75	10.30 pg/mL Interval 6.93 to 24.25

SECONDARY outcome

Timeframe: 4 weeks

Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
TNF Alpha	13.07 pg/mL Interval 8.55 to 20.58	9.07 pg/mL Interval 6.27 to 11.81

SECONDARY outcome

Timeframe: 4 weeks

Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL

Outcome measures

Measure	CD4<100 n=26 Participants Subjects with baseline CD4 count \< 100 cells/mm3	CD4>/=100 n=34 Participants CD4 count greater than or equal 100 cells/mm3
INF Gamma	2.24 pg/mL Interval 0.18 to 34.03	1.06 pg/mL Interval 0.15 to 4.74

Adverse Events

Truvada/Kaletra CD4<100

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Truvada/Kaletra CD4>/=100

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Truvada/Kaletra CD4<100 n=26 participants at risk	Truvada/Kaletra CD4>/=100 n=34 participants at risk
Nervous system disorders Peripheral neuropathy	3.8% 1/26 • Number of events 1 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	0.00% 0/34 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm

Other adverse events

Measure	Truvada/Kaletra CD4<100 n=26 participants at risk	Truvada/Kaletra CD4>/=100 n=34 participants at risk
Gastrointestinal disorders Diarrhea	19.2% 5/26 • Number of events 5 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	14.7% 5/34 • Number of events 5 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm
General disorders Fatigue	92.3% 24/26 • Number of events 35 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	88.2% 30/34 • Number of events 47 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm
General disorders Fevers	34.6% 9/26 • Number of events 9 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	14.7% 5/34 • Number of events 6 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm
Gastrointestinal disorders Nausea	23.1% 6/26 • Number of events 9 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	11.8% 4/34 • Number of events 7 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm
Psychiatric disorders Anxiety	11.5% 3/26 • Number of events 4 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	14.7% 5/34 • Number of events 7 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm
General disorders Night Sweats	46.2% 12/26 • Number of events 16 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm	29.4% 10/34 • Number of events 13 • 6 months All participants received the same treatment intervention, an FDA approved combination at the time of the study. Adverse events from the treatment are reported by CD4 group as determined at baseline \<100 or greater than/equal to 100 cells/cu mm

Additional Information

Dr. Carl J. Fichtenbaum

University of Cincinnati

Phone: 513-584-6361

Email: carl.fichtenbaum@uc.edu

Results disclosure agreements

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

Restriction type: LTE60