ART Start at week 0 non-stop.
FMT. The frozen capsules will be ingested orally at a frequency of 15 capsules every 12 hours for four doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Each capsule must be ingested over a period no longer than 1 hour of the anterior capsule.
Blood samples Week 0, 4, 8, 12 and 24. Taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the CD4 lymphocytes count and HIV viral load.
Feces samples from each patient will be taken during medical consultation on week 0, 8 and 24 after ART start to evaluate the modification of the intestinal microbiome.
Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.

ART Start at week 0 non-stop.
Placebo capsules. The frozen capsules will be ingested orally at a frequency of 15 capsules every 12 hours for four doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Each capsule must be ingested over a period no longer than 1 hour of the anterior capsule.
Blood samples Week 0, 4, 8, 12 and 24. Taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the CD4 lymphocytes count and HIV viral load.
Feces samples from each patient will be taken during medical consultation on week 0, 8 and 24 after ART start to evaluate the modification of the intestinal microbiome.
Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.

HIV Infections

Blood samples are going to be taken by puncturing peripheral vein extraction with 10 ml of venous blood for later biweekly to monitor in person and therefore monitor immune status with biomarkers T lymphocyte subclass CD4 and viral load. A total of four blood samples will be taken at weeks 4, 8, 12 and 24 of recruitment.
A total of four feces samples are going to be required during the study, to evaluate the changes on the microbiota of the patient. 1 week before the patients start their HAART, the same day the patients initiate their HAART, 8 weeks after they started HAART and 24 weeks after HAART.

Blood and feces samples

Hospital Universitario José E. Gonzalez

Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV

The efficacy of FMT in obtaining a faster immunologic response measured in rise of CD4 lymphocyte countTMF capsules, will have a faster rise in cell count than those who don´t receive them.

Number of Participants with FMT related Adverse Events

Dr. Adrian Camacho-Ortiz

Dr. Adrian Camacho Ortiz

Hospital Universitario Dr. Jose E. Gonzalez

Prospective controlled study experimental comparative

Neither patients, nor investigators are allowed to know about which group of patients is going to receive placebo and which one faecal microbiota capsules. The laboratory that provide us the capsules is going to divide and randomize our sample of patients, and also register the information in a data base.

Dronabinol 2.5 mg will be taken orally with water twice per day for two days.

Dronabinol 5 mg will be taken orally with water twice per day for two days.

Placebo will be taken orally with water twice per day for two days.

Dronabinol 2.5 mg Bid

Dronabinol 5 mg Bid

Placebo

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index (BMI)

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

Colonic Transit Geometric Center

The time for half of the ingested solids or liquids to leave the stomach.

Gastric Emptying Half-Time (t1/2)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Colonic Filling at 6 Hours

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

Ascending Colon Emptying T 1/2

Proportion of stomach contents emptied at a 2 and 4 hours.

Gastric Emptying at 2 and 4 Hours

Colonic Transit Geometric Center at 24 Hours

Overall Study

Dr. Michael Camilleri

Irritable Bowel Syndrome

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.

Dronabinol

Placebo will match study drug; taken orally with water twice per day for two days.

Mayo Clinic

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

Study of the Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor and Sensory Functions in Patients With Irritable Bowel Syndrome

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Center for Research Resources (NCRR)

300 mg of testosterone enanthate by intramuscular injection once weekly for 16 weeks

Placebo (sesame oil) by intramuscular injection once weekly for 16 weeks

HIV Associate Weight Loss

Testosterone enanthate

Charles R. Drew University

Testosterone and Physical Function in HIV+ Men

Testosterone and Physical Function in HIV Associate Weight Loss

A modification of the Margaria stair climb was used to assess stair-climbing power. participants were instructed to ascend a 12-step staircase as rapidly as possible, with ascent time recorded over the middle four steps (0.66 m) of the climb.

Participants were instructed to walk a 160-m flat course as fast as possible without running. Photoelectric cells and timers were used to determine time to the nearest 0.01 s. The faster of two trials was used to calculate walking speed (m/s).

To simulate daily activities such as carrying groceries or suitcases, participants carried a load equal to 20% of their body weight while walking a distance of 20 m as fast as possible on a flat course.

glycerol/diarrhea

Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

Testosterone and Physical Function in HIV+ Men

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