HIV-1-infection on Healthy Volunteers
Conditions
Keywords
HIV, Dolutegravir, Insulin
Brief summary
This study will investigate changes in insulin resistance, lipid metabolism and endocrine profile in HIV-negative subjects exposed to dolutegravir (an antiretroviral drug used in HIV treatment) in order to investigate the role all these different factors may potentially have in weight gain recently reported in clinical cohorts.
Detailed description
A randomised, crossover study investigating the difference in changes in insulin sensitivity (determined by peripheral glucose uptake using a euglycaemic clamp) with the administration of dolutegravir (DTG) compared to no DTG for 28 days in HIV seronegative healthy volunteers. Participants will be randomised 1:1 to one of two arms: Group 1: * Dolutegravir 50 mg once daily for the first 28 days of the study. * No treatment for the last 44 days of the study. Group 2: * No treatment for the first 28 days of the study. * Dolutegravir 50 mg once daily for the last 28 days of the study (day 44-72). Research bloods, endocrine profiles, weight and urine samples will be collected at baseline, as well as day 28, 44, and 72 to enable comparative analyses. Participants will be closely monitored whilst taking the study medications. Participants will exit the study 72 days post-randomisation, with a follow-up call 28 days after exiting.
Interventions
DRUGDolutegravir
50 mg once daily orally
Sponsors
Chelsea and Westminster NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomised to start on dolutegravir 50 mg once daily OR no treatment for the first 28 day dosing phase of the study then will cross over to the alternative for the second dosing phase, following a 2 week washout period (equivalent to 5+ dolutegravir elimination half-lives).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to provide informed consent * Cis-Male and Cis-Female healthy subjects without underlying conditions * Subjects must have documented negative HIV serology by ELISA and P24 antigen and not receiving anti-HIV pre-exposure prophylaxis (PreP) * Subjects must be clinically well volunteers aged between 18 to 60 years with BMI \<30 kg/m2 but \>18 kg/m2 * Healthy, as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (including ECG) * Non-fasting blood glucose, total cholesterol and triglycerides within normal limits * Subjects should have complete blood count (FBC) with normal differential and platelet count (detail below of specified normal range, table 1) Table 1 - Compete FBC with normal differential & platelets count ranges Test Male Normal Range Female Normal Range Haemoglobin (g/L) 130-168 114-150 White blood cell count (x109/L) 4.2-10.6 4.2-11.2 Neutrophil count (x109/L) 2.0 - 7.1 Lymphocyte count (x109/L) 1.1 - 3.6 Monocyte count (x109/L) 0.2 - 0.9 Eosinophil count (x109/L) 0.0 - 0.5 Basophil count (x109/L) 0.0 - 0.2 * A female, may be eligible to enter and participate in the study if she: * is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or, * is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy: * Complete abstinence from penile-vaginal intercourse. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant; * Any intrauterine device with published data showing that the expected failure rate is \<1% per year (not all intrauterine devices meet this criterion, see Appendix 6\] for an example listing of approved intrauterine devices); * Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject; * Approved hormonal contraception (see Appendix 6\] for a listing of examples of approved hormonal contraception)\*; * Any other method with published data showing that the expected failure rate is \<1% per year * Men who have partners who are women of childbearing potential (WOCBP - definition in Appendix 6) must be using an adequate method of contraception to avoid pregnancy in their partner throughout the study and for a period of at least 4 weeks after the study; * Complete abstinence from penile-vaginal intercourse. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient; * Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); * Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion, see Appendix 4 for an example listing of approved IUDs) plus male condom; * Sterilisation confirmed prior to the subject's entry into the study * Approved hormonal contraception used by female partner (see protocol appendix 4 for a listing of examples of approved hormonal contraception) plus male condom; * Any other method with published data showing that the expected failure rate is \<1% per year and not containing hormones plus male condom. * Any contraception method must be used consistently, in accordance with the approved product label and for at least four weeks after discontinuation of IMP (Appendix 6). Any contraception method must be used consistently, in accordance with the approved product label and for at least 28 days prior to the first dose of study medication and 4 weeks after discontinuing the study medication. 4.1.2
Exclusion criteria
* Subjects with a waist hip ratio \> 0.97 or BMI \> 30kg/m2 and BMI \<18 kg/m2 will be excluded * Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit) * Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit) * Diabetes mellitus, other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension. Subject with HbA1c \>42 mmol/mol will be excluded. * History or presence of allergy to the dolutegravir * ALT or AST greater than or equal to 1.5 x Upper Limit of Normal (ULN) and total bilirubin greater than or equal to 1.5 x ULN excluded; * Pregnancy and breastfeeding women * Alcohol consumption \>10 units/week * Clinically relevant drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study. * Unable to refrain from the use of prescription (e.g., dofetilide) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives prior to the baseline visit and throughout the study until the follow-up period, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise participant safety. * This includes on-going therapy with any of the following * Metabolically active medications * Any lipid-lowering medication * Any testosterones treatments or supplements - Glucocorticoids including inhaled steroids except for 'as necessary' use * Beta-blockers * Thiazide diuretics and indapamide * Thyroid preparations * Psychotropic agents * Anabolic steroids * Megestrol acetate * Dofetilide (or pilsicainide)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Baseline, day 28 and 72 for both groups. | Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Dolutegravir on Pituitary Hormones | Baseline, day 28 and 72 for both groups. | Cortisol |
| Effect of Dolutegravir on Changes in Indirect Calorimetry | Baseline, day 28 and 72 for both groups. | Indirect calorimetry by ventilated hood expires gas analysis will be used to determine energy expenditure during the course of the clamp procedures. |
| Effect of Dolutegravir on Adipocytokines. | Baseline, day 28 and 72 for both groups. | Fasting adiponectin levels in blood. |
| Changes in Food Intake by Food Preference Questionnaire | Baseline, day 28 and 72 for both groups. | Changes in food intake Food preference questionnaire for adolescents and adults (FPQ) 1- Scoring of Individual Items Each food item is rated on a 5-point Likert scale: 1. = Dislike a lot 2. = Dislike a little 3. = Neither like nor dislike 4. = Like a little 5. = Like a lot Responses marked as Not applicable are treated as missing and not included in scoring. Food Category Scores Items are grouped into six categories, each scored by averaging across the foods in that group: Vegetables (18 items) Fruits (7 items) Meat/Fish (12 items) Dairy (10 items) Snacks (9 items) Starches (6 items) The category score is the mean of item scores in that category (sum ÷ number of items). For both individual items and category scores: Minimum possible score = 1 (Dislike a lot) Maximum possible score = 5 (Like a lot) Direction of Scoring On the FPQ, higher scores reflect greater liking of the foods, Lower scores indicate less liking. 'scores on a scale' |
| Change in Sleep Parameters by Sleep Questionnaires | Baseline, day 28 and 72 for both groups. | changes in sleep parameters by Pittsbrough Sleep Quality Index (PSQI) 1. Scoring Components The PSQI has 19 self-rated items, grouped into 7 component scores: Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction Each component is scored from 0 to 3, where higher values indicate worse sleep in that domain. 2. Global Score The 7 component scores are summed to yield a global PSQI score ranging from 0 to 21. 0 = no difficulty / very good sleep quality 21 = severe difficulties / very poor sleep quality 3- Interpretation A global score \> 5 is commonly used as a cut-off to distinguish between good sleepers (≤5) and poor sleepers (\>5). 4- Direction of Scoring On the PSQI, higher scores indicate worse outcomes (poorer sleep quality). Lower scores indicate better sleep quality. Unit of Measue = Score on a scale |
| Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Baseline, day 28 and 72 for both groups. | Total Cholesterol |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 * Dolutegravir - 50 mg once daily, orally administered for the first 28 days of the study.
* No treatment for the last 44 days of the study.
Dolutegravir: 50 mg once daily orally | 7 |
| Arm 2 * No treatment for the first 28 days of the study.
* Dolutegravir - 50 mg once daily, orally administered for the last 28 days of the study (day 44-72).
Dolutegravir: 50 mg once daily orally | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 7 / 7 | 7 / 7 | 8 / 8 | 8 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 1 / 8 | 0 / 8 |
Outcome results
Primary
Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups.
Change in insulin sensitivity will be determined by peripheral glucose uptake using a euglycaemic clamp.
Time frame: Baseline, day 28 and 72 for both groups.
Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Baseline | 7.749985 (mg/kg/min) | Standard Deviation 3.520332 |
| Arm 1 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Day 28 | 8.716221 (mg/kg/min) | Standard Deviation 2.600469 |
| Arm 1 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Day 72 | 10.62598 (mg/kg/min) | Standard Deviation 5.250227 |
| Arm 2 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Baseline | 6.286017 (mg/kg/min) | Standard Deviation 2.072026 |
| Arm 2 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Day 28 | 6.815305 (mg/kg/min) | Standard Deviation 2.404083 |
| Arm 2 | Change in Insulin Sensitivity in Participants From Baseline to End of Study Between Two Crossover Groups. | Day 72 | 7.684051 (mg/kg/min) | Standard Deviation 2.516086 |
Secondary
Change in Sleep Parameters by Sleep Questionnaires
changes in sleep parameters by Pittsbrough Sleep Quality Index (PSQI) 1. Scoring Components The PSQI has 19 self-rated items, grouped into 7 component scores: Subjective sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction Each component is scored from 0 to 3, where higher values indicate worse sleep in that domain. 2. Global Score The 7 component scores are summed to yield a global PSQI score ranging from 0 to 21. 0 = no difficulty / very good sleep quality 21 = severe difficulties / very poor sleep quality 3- Interpretation A global score \> 5 is commonly used as a cut-off to distinguish between good sleepers (≤5) and poor sleepers (\>5). 4- Direction of Scoring On the PSQI, higher scores indicate worse outcomes (poorer sleep quality). Lower scores indicate better sleep quality. Unit of Measue = Score on a scale
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Change in Sleep Parameters by Sleep Questionnaires | Baseline | 4.714286 Global PSQI score | Standard Deviation 1.799371 |
| Arm 1 | Change in Sleep Parameters by Sleep Questionnaires | Day 28 | 4.571429 Global PSQI score | Standard Deviation 4.117327 |
| Arm 1 | Change in Sleep Parameters by Sleep Questionnaires | Day 72 | 4.125 Global PSQI score | Standard Deviation 2.10017 |
| Arm 2 | Change in Sleep Parameters by Sleep Questionnaires | Baseline | 2.5 Global PSQI score | Standard Deviation 1.414214 |
| Arm 2 | Change in Sleep Parameters by Sleep Questionnaires | Day 28 | 2.5 Global PSQI score | Standard Deviation 1.85164 |
| Arm 2 | Change in Sleep Parameters by Sleep Questionnaires | Day 72 | 1.88889 Global PSQI score | Standard Deviation 1.536591 |
Secondary
Changes in Food Intake by Food Preference Questionnaire
Changes in food intake Food preference questionnaire for adolescents and adults (FPQ) 1- Scoring of Individual Items Each food item is rated on a 5-point Likert scale: 1. = Dislike a lot 2. = Dislike a little 3. = Neither like nor dislike 4. = Like a little 5. = Like a lot Responses marked as Not applicable are treated as missing and not included in scoring. Food Category Scores Items are grouped into six categories, each scored by averaging across the foods in that group: Vegetables (18 items) Fruits (7 items) Meat/Fish (12 items) Dairy (10 items) Snacks (9 items) Starches (6 items) The category score is the mean of item scores in that category (sum ÷ number of items). For both individual items and category scores: Minimum possible score = 1 (Dislike a lot) Maximum possible score = 5 (Like a lot) Direction of Scoring On the FPQ, higher scores reflect greater liking of the foods, Lower scores indicate less liking. 'scores on a scale'
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Changes in Food Intake by Food Preference Questionnaire | Baseline | 3.719047619 scores on a scale | Standard Deviation 0.464914105 |
| Arm 1 | Changes in Food Intake by Food Preference Questionnaire | Day 28 | 3.654285714 scores on a scale | Standard Deviation 0.434338447 |
| Arm 1 | Changes in Food Intake by Food Preference Questionnaire | Day 72 | 3.726428571 scores on a scale | Standard Deviation 0.44250229 |
| Arm 2 | Changes in Food Intake by Food Preference Questionnaire | Baseline | 4.0375 scores on a scale | Standard Deviation 0.458087055 |
| Arm 2 | Changes in Food Intake by Food Preference Questionnaire | Day 28 | 4.066666667 scores on a scale | Standard Deviation 0.339461379 |
| Arm 2 | Changes in Food Intake by Food Preference Questionnaire | Day 72 | 3.983958333 scores on a scale | Standard Deviation 0.561874305 |
Secondary
Effect of Dolutegravir on Adipocytokines.
Fasting adiponectin levels in blood.
Time frame: Baseline, day 28 and 72 for both groups.
Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Baseline | 7066.733 ng/mL | Standard Deviation 4002.151 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Day 28 | 7573.153 ng/mL | Standard Deviation 4832.789 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Day 72 | 6531.739 ng/mL | Standard Deviation 3687.814 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Baseline | 7555.781 ng/mL | Standard Deviation 4201.587 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Day 28 | 8294.638 ng/mL | Standard Deviation 5464.168 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Adiponectin Day 72 | 9220.179 ng/mL | Standard Deviation 5437.189 |
Secondary
Effect of Dolutegravir on Adipocytokines.
Fasting Leptin levels in blood.
Time frame: Baseline, day 28 & 72 for both groups.
Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Leptin Baseline | 8.687143 ug/L | Standard Deviation 5.559331 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Leptin Day 28 | 12.16571 ug/L | Standard Deviation 10.39278 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Leptin Day 72 | 13.768 ug/L | Standard Deviation 8.141939 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Leptin Baseline | 12.58571 ug/L | Standard Deviation 11.13826 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Leptin Day 28 | 10.57286 ug/L | Standard Deviation 8.23104 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Leptin Day 72 | 12.22 ug/L | Standard Deviation 9.240835 |
Secondary
Effect of Dolutegravir on Adipocytokines.
Fasting Ghrelin levels in blood.
Time frame: Baseline, day 28 & 72 for both groups.
Population: Dolutegravir versus No Treatment Two sample Wilcoxon rank sum (Mann Whitney) test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Baseline | 3555.059 ng/L | Standard Deviation 2749.332 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Day 28 | 1873.901 ng/L | Standard Deviation 1817.324 |
| Arm 1 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Day 72 | 4557.219 ng/L | Standard Deviation 4493.846 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Baseline | 3873.6 ng/L | Standard Deviation 2962.185 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Day 28 | 4171.744 ng/L | Standard Deviation 1671.54 |
| Arm 2 | Effect of Dolutegravir on Adipocytokines. | Ghrelin Day 72 | 2826.041 ng/L | Standard Deviation 2823.855 |
Secondary
Effect of Dolutegravir on Changes in Indirect Calorimetry
Indirect calorimetry by ventilated hood expires gas analysis will be used to determine energy expenditure during the course of the clamp procedures.
Time frame: Baseline, day 28 and 72 for both groups.
Secondary
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Triglycerides
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Baseline | 0.7214286 mmol /L | Standard Deviation 0.310023 |
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 28 | 0.8342857 mmol /L | Standard Deviation 0.3867754 |
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 72 | 0.62375 mmol /L | Standard Deviation 0.4254388 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Baseline | 0.87 mmol /L | Standard Deviation 2186974 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 28 | 0.76 mmol /L | Standard Deviation 0.1962506 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 72 | 0.6355556 mmol /L | Standard Deviation 0.3005458 |
Secondary
Effect of Dolutegravir on Lipid Profile Including Lipid Fractions
Total Cholesterol
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Baseline | 4.071429 mmol /L | Standard Deviation 0.3638419 |
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 28 | 3.681429 mmol /L | Standard Deviation 1.076358 |
| Arm 1 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 72 | 2.965 mmol /L | Standard Deviation 1.397252 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Baseline | 4.25 mmol /L | Standard Deviation 0.8244305 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 28 | 4.165 mmol /L | Standard Deviation 0.5593619 |
| Arm 2 | Effect of Dolutegravir on Lipid Profile Including Lipid Fractions | Day 72 | 3.867778 mmol /L | Standard Deviation 1.775414 |
Secondary
Effect of Dolutegravir on Pituitary Hormones
Luteinsing Hormone Level
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 4.585714 mIU /L | Standard Deviation 5.440107 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 3.171429 mIU /L | Standard Deviation 1.900626 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 2.4 mIU /L | Standard Deviation 1.656157 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 2.1625 mIU /L | Standard Deviation 0.8667468 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 2.825 mIU /L | Standard Deviation 0.9852483 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 2.355556 mIU /L | Standard Deviation 1.35904 |
Secondary
Effect of Dolutegravir on Pituitary Hormones
Prolactin
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 261 mIU /L | Standard Deviation 117.5131 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 173.7143 mIU /L | Standard Deviation 110.7019 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 238.5 mIU /L | Standard Deviation 112.5052 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 196.625 mIU /L | Standard Deviation 54.52113 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 231.5 mIU /L | Standard Deviation 138.0497 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 227.1111 mIU /L | Standard Deviation 86.96327 |
Secondary
Effect of Dolutegravir on Pituitary Hormones
Cortisol
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 229.7143 nmol /L | Standard Deviation 106.6173 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 290.8571 nmol /L | Standard Deviation 116.7325 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 233.375 nmol /L | Standard Deviation 102.841 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 307.25 nmol /L | Standard Deviation 116.4643 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 304 nmol /L | Standard Deviation 102.0868 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 272.8889 nmol /L | Standard Deviation 116.7994 |
Secondary
Effect of Dolutegravir on Pituitary Hormones
Growth Hormone
Time frame: Baseline, day 28 and 72 for both groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 0.1642857 μg /L | Standard Deviation 0.1137039 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 1.144286 μg /L | Standard Deviation 2.545361 |
| Arm 1 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 0.58375 μg /L | Standard Deviation 1.241818 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Baseline | 0.15875 μg /L | Standard Deviation 0.1211183 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 28 | 0.85 μg /L | Standard Deviation 1.859416 |
| Arm 2 | Effect of Dolutegravir on Pituitary Hormones | Day 72 | 0.3322222 μg /L | Standard Deviation 0.6257551 |