Trial Outcomes & Findings for Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects (NCT NCT00991289)
NCT ID: NCT00991289
Last Updated: 2021-11-04
Results Overview
Complete early virologic response (cEVR) was defined as undetectable HCV viral load (\<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
COMPLETED
PHASE2
68 participants
Week 16
2021-11-04
Participant Flow
Men and women at least 18 years of age with genotype 1 hepatitis C virus (HCV) and human immunodeficiency virus (HIV) coinfection and naive to previous HCV treatment were recruited for participation in this study.
Participant milestones
| Measure |
NTZ/PEG/RBV
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED Week 16
|
61
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
NTZ/PEG/RBV
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects
Baseline characteristics by cohort
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Age, Customized
<25 years
|
1 participants
n=5 Participants
|
|
Age, Customized
25 to <30 years
|
1 participants
n=5 Participants
|
|
Age, Customized
30 to <35 years
|
4 participants
n=5 Participants
|
|
Age, Customized
35 to <40 years
|
3 participants
n=5 Participants
|
|
Age, Customized
40 to <45 years
|
11 participants
n=5 Participants
|
|
Age, Customized
45 to <50 years
|
13 participants
n=5 Participants
|
|
Age, Customized
50 to <55 years
|
18 participants
n=5 Participants
|
|
Age, Customized
55 to 60 years
|
13 participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, Non-Hispanic
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Regardless of Race
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=5 Participants
|
|
HCV viral load level
|
6.4 log10 IU/ml
n=5 Participants
|
|
CD4+ T cell count
|
452 cells/mm3
n=5 Participants
|
|
Number of participants with indicated HIV viral load
Undetectable HIV viral load
|
49 participants
n=5 Participants
|
|
Number of participants with indicated HIV viral load
Detectable HIV viral load
|
16 participants
n=5 Participants
|
|
Number of participants with indicated HIV viral load
Unknown
|
2 participants
n=5 Participants
|
|
HIV Antiretroviral therapy (ART) status
On ART
|
61 participant
n=5 Participants
|
|
HIV Antiretroviral therapy (ART) status
Not on ART
|
6 participant
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.
Complete early virologic response (cEVR) was defined as undetectable HCV viral load (\<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR)
|
38.8 percentage of participants
Interval 28.8 to 49.6
|
PRIMARY outcome
Timeframe: Weeks 0, 16Population: All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.
Early virologic response (EVR) was defined as undetectable HCV viral load (\<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percentage of Participants With Early Virologic Response (EVR)
|
65.7 percentage of participants
Interval 55.0 to 75.3
|
SECONDARY outcome
Timeframe: 24 weeks after treatment discontinuationPopulation: All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.
Sustained virologic response (SVR) was defined as undetectable HCV viral load (\<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR)
|
32.8 percentage of participants
Interval 23.4 to 43.5
|
SECONDARY outcome
Timeframe: Week 8Population: All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.
Rapid virologic response (RVR) was defined as undetectable HCV viral load (\<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
10.4 percentage of participants
Interval 5.0 to 18.7
|
SECONDARY outcome
Timeframe: From study entry to up to week 76Population: All participants who enrolled, except one participant who was found to have been ineligible after entry.
Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Number of Participants With Adverse Events of Grade 2 or Higher
|
65 participants
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.Population: All participants who enrolled (except one participant who was found to have been ineligible after entry) and had HGB measurements available at entry and at the respective post-entry time point.
Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 40
|
-2.6 g/dL
Interval -3.4 to -2.1
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 44
|
-2.6 g/dL
Interval -3.9 to -1.6
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 48
|
-2.7 g/dL
Interval -3.4 to -1.9
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 4
|
-0.1 g/dL
Interval -0.6 to 0.4
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 8
|
-2.1 g/dL
Interval -3.0 to -1.1
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 12
|
-2.5 g/dL
Interval -3.5 to -1.8
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 16
|
-2.5 g/dL
Interval -3.5 to -1.4
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 20
|
-2.5 g/dL
Interval -3.8 to -1.3
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 24
|
-2.4 g/dL
Interval -3.2 to -1.3
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 28
|
-2.5 g/dL
Interval -3.4 to -1.6
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 32
|
-2.7 g/dL
Interval -3.4 to -1.7
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 36
|
-2.5 g/dL
Interval -3.9 to -1.7
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 52
|
-2.9 g/dL
Interval -3.8 to -1.6
|
|
Change in Hemoglobin Level From Study Entry
Change in HGB at Week 76
|
-0.9 g/dL
Interval -1.3 to -0.5
|
SECONDARY outcome
Timeframe: Weeks 0, 16, 28, 52, and 76Population: All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FINS measurements available at entry and the respective post-entry time point.
Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percent Change in Fasting Insulin Level From Study Entry
Percent change in FINS at Week 16
|
0 percentage of FINS at study entry
Interval -30.8 to 64.7
|
|
Percent Change in Fasting Insulin Level From Study Entry
Percent change in FINS at Week 28
|
8.8 percentage of FINS at study entry
Interval -33.2 to 67.9
|
|
Percent Change in Fasting Insulin Level From Study Entry
Percent change in FINS at Week 52
|
28.2 percentage of FINS at study entry
Interval -15.0 to 87.5
|
|
Percent Change in Fasting Insulin Level From Study Entry
Percent change in FINS at Week 76
|
8.3 percentage of FINS at study entry
Interval -48.0 to 56.3
|
SECONDARY outcome
Timeframe: Weeks 0, 16, 28, 52, and 76Population: All participants who enrolled (except one participant who was found to have been ineligible after entry) and had FGLUC measurements available at entry and the respective post-entry time point.
Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percent Change in Fasting Glucose Level From Study Entry
Percent change in FGLUC at Week 16
|
-3.2 percentage of FGLUC at study entry
Interval -12.6 to 7.0
|
|
Percent Change in Fasting Glucose Level From Study Entry
Percent change in FGLUC at Week 28
|
-5.3 percentage of FGLUC at study entry
Interval -9.9 to 4.9
|
|
Percent Change in Fasting Glucose Level From Study Entry
Percent change in FGLUC at Week 52
|
1.1 percentage of FGLUC at study entry
Interval -11.8 to 8.0
|
|
Percent Change in Fasting Glucose Level From Study Entry
Percent change in FGLUC at Week 76
|
0 percentage of FGLUC at study entry
Interval -7.4 to 8.4
|
SECONDARY outcome
Timeframe: Weeks 0, 16, 28, 52, and 76Population: All participants who enrolled (except one participant who was found to have been ineligible after entry) and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point.
HOMA-IR was calculated as \[fasting glucose (mg/dL) x fasting insulin (uIU/mL)\]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Percent change in HOMA-IR at Week 16 (n=56)
|
-13.0 percentage of HOMA-IR at study entry
Interval -31.6 to 64.2
|
|
Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Percent change in HOMA-IR at Week 28 (n=39)
|
-6.3 percentage of HOMA-IR at study entry
Interval -42.7 to 81.1
|
|
Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Percent change in HOMA-IR at Week 52 (n=27)
|
23.2 percentage of HOMA-IR at study entry
Interval -24.2 to 87.1
|
|
Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry
Percent change in HOMA-IR at Week 76 (n=22)
|
9.5 percentage of HOMA-IR at study entry
Interval -48.0 to 59.5
|
SECONDARY outcome
Timeframe: Weeks 0, 4Population: All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.
Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.
Outcome measures
| Measure |
NTZ/PEG/RBV
n=64 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.
|
-0.12 log10 IU/mL
Interval -0.3 to 0.13
|
SECONDARY outcome
Timeframe: Week 0Population: All participants who enrolled, except one participant who was found to have been ineligible after entry.
Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).
Outcome measures
| Measure |
NTZ/PEG/RBV
n=67 Participants
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Number of Participants With HCV Genotype 1
|
67 participants
|
Adverse Events
NTZ/PEG/RBV
Serious adverse events
| Measure |
NTZ/PEG/RBV
n=67 participants at risk
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
2/67 • From study entry to Week 76.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
3/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
2/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Haematemesis
|
1.5%
1/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/67 • From study entry to Week 76.
|
|
General disorders
Pyrexia
|
1.5%
1/67 • From study entry to Week 76.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/67 • From study entry to Week 76.
|
|
Infections and infestations
Pneumonia
|
4.5%
3/67 • From study entry to Week 76.
|
|
Infections and infestations
Urosepsis
|
1.5%
1/67 • From study entry to Week 76.
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.5%
1/67 • From study entry to Week 76.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.5%
1/67 • From study entry to Week 76.
|
|
Nervous system disorders
Syncope
|
1.5%
1/67 • From study entry to Week 76.
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/67 • From study entry to Week 76.
|
|
Renal and urinary disorders
Renal failure acute
|
1.5%
1/67 • From study entry to Week 76.
|
Other adverse events
| Measure |
NTZ/PEG/RBV
n=67 participants at risk
Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.9%
12/67 • From study entry to Week 76.
|
|
Blood and lymphatic system disorders
Neutropenia
|
23.9%
16/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
7/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
4/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Diarrhoea
|
26.9%
18/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Dysphagia
|
6.0%
4/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
13/67 • From study entry to Week 76.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
6/67 • From study entry to Week 76.
|
|
General disorders
Fatigue
|
34.3%
23/67 • From study entry to Week 76.
|
|
General disorders
Irritability
|
6.0%
4/67 • From study entry to Week 76.
|
|
General disorders
Pain
|
7.5%
5/67 • From study entry to Week 76.
|
|
General disorders
Pyrexia
|
7.5%
5/67 • From study entry to Week 76.
|
|
Infections and infestations
Pneumonia bacterial
|
6.0%
4/67 • From study entry to Week 76.
|
|
Investigations
Alanine aminotransferase increased
|
53.7%
36/67 • From study entry to Week 76.
|
|
Investigations
Aspartate aminotransferase increased
|
43.3%
29/67 • From study entry to Week 76.
|
|
Investigations
Blood albumin abnormal
|
10.4%
7/67 • From study entry to Week 76.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.0%
6/67 • From study entry to Week 76.
|
|
Investigations
Blood bicarbonate abnormal
|
7.5%
5/67 • From study entry to Week 76.
|
|
Investigations
Blood bilirubin increased
|
20.9%
14/67 • From study entry to Week 76.
|
|
Investigations
Blood glucose abnormal
|
16.4%
11/67 • From study entry to Week 76.
|
|
Investigations
Blood glucose increased
|
9.0%
6/67 • From study entry to Week 76.
|
|
Investigations
Blood phosphorus decreased
|
20.9%
14/67 • From study entry to Week 76.
|
|
Investigations
Blood potassium decreased
|
9.0%
6/67 • From study entry to Week 76.
|
|
Investigations
Blood sodium decreased
|
13.4%
9/67 • From study entry to Week 76.
|
|
Investigations
Blood triglycerides abnormal
|
6.0%
4/67 • From study entry to Week 76.
|
|
Investigations
Blood uric acid increased
|
16.4%
11/67 • From study entry to Week 76.
|
|
Investigations
Haemoglobin decreased
|
35.8%
24/67 • From study entry to Week 76.
|
|
Investigations
Lipase increased
|
16.4%
11/67 • From study entry to Week 76.
|
|
Investigations
Neutrophil count decreased
|
80.6%
54/67 • From study entry to Week 76.
|
|
Investigations
Platelet count decreased
|
52.2%
35/67 • From study entry to Week 76.
|
|
Investigations
Weight decreased
|
31.3%
21/67 • From study entry to Week 76.
|
|
Investigations
White blood cell count decreased
|
34.3%
23/67 • From study entry to Week 76.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.9%
14/67 • From study entry to Week 76.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
5/67 • From study entry to Week 76.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
5/67 • From study entry to Week 76.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
5/67 • From study entry to Week 76.
|
|
Nervous system disorders
Dizziness
|
13.4%
9/67 • From study entry to Week 76.
|
|
Nervous system disorders
Headache
|
10.4%
7/67 • From study entry to Week 76.
|
|
Psychiatric disorders
Anxiety
|
7.5%
5/67 • From study entry to Week 76.
|
|
Psychiatric disorders
Depression
|
13.4%
9/67 • From study entry to Week 76.
|
|
Psychiatric disorders
Insomnia
|
7.5%
5/67 • From study entry to Week 76.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
5/67 • From study entry to Week 76.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
7/67 • From study entry to Week 76.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
4/67 • From study entry to Week 76.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.0%
4/67 • From study entry to Week 76.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.0%
4/67 • From study entry to Week 76.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.0%
4/67 • From study entry to Week 76.
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trial 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