Early Phase 1 N=76 Autonomic Neuropathy, GI Motility, and Inflammation in HIV
HIV Disease
Primary: Change in Breath Test — 28; 14 ppm
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N/A N=103 Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy
HIV-associated Enteropathy
Primary: Frequency of Daily Unformed Bowel Movements — -2.46; -2.16; -2.20 abnormal or unformed stools
N/A N=120 HIV And Parasitic Infection (HAPI) Study
HIV Coinfection
Primary: Number of Participants With and Without Intestinal Parasitic Infection — 36; 84 Participants
Early Phase 1 N=8 CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements
HIV
Primary: Number of Bowel Movements Per Day — 5.8; 2 bowel movements/day — p=0.008
Phase 2 N=80 The Role of Probiotics in HIV Patients With Immunological Non-Responder
HIV Infections · Immunological Abnormality
Primary: CD4+ Level — 162.3; 50.5; 143.3; 69.9 cell/μL — p=0.02
Phase 3 N=250 Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
HIV Enteropathy · Diarrhea With HIV
Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). — 189; 20 Participants
Phase 2 N=32 A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
HIV
Primary: Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake — -0.28; 0.01 ratio — p=0.01
N/A N=40 The Study of Gut Associated Lymphocytes in HIV and HCV/HIV Co-infected Patients
HIV · Hepatitis C, Chronic · HCV Coinfection
Primary: Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients. — 5.8; 5.84; 5.84; 6.9 relative expression levels
N/A N=147 Trial of Rifaximin in the Treatment of Tropical Enteropathy
Tropical Enteropathy
Primary: Difference in the Urinary L:M Ratio Before and After the Intervention — -0.01; 0.02 Ratio of lactulose-to-mannitol (L:M) exc
Phase 3 N=374 Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
HIV Associated Diarrhea
Primary: Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose…
Phase 4 N=44 A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy
HIV Infections
Primary: Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen — 24; 89; 119; 566…
N/A N=215 Incidence of HANA Conditions in HIV-infected Individuals
HIV · Metabolic Syndrome · Osteopenia
Primary: Prevalences of HIV-associated Non-AIDS Conditions (HANA) — 69; 15; 30; 4 Participants — p=0.244
Phase 2 N=20 Improving Prognosis in HIV Infection
Human Immunodeficiency Virus
Primary: Adverse Effects — 1 Participants
Phase 2 N=46 Rifaximin for Chronic Immune Activation in People With HIV
HIV
Primary: Changes in Soluble Cluster of Differentiation 14 (sCD14) Levels Between the Placebo and Rifaximin Phases of the Study — 0.0067; 0.0035 mcg/mL — p=0.51
N/A N=27 Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance
HIV Related Insulin Resistance · Protease Inhibitor Related Insulin Resistance · Endoplasmic Reticulum Stress
Primary: Glucose Uptake — 0; 8 change in glucose infusion rate (ml/hr)
Phase 4 N=20 Metabolic Abnormalities in HIV-infected Persons
Lipodystrophy · HIV Infection
Primary: Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent — -0.25; -0.96 mg/kg lean body mass/min
Phase 4 N=52 IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
HIV Positive · Malnourished
Primary: Grade 3 or Higher Adverse Events Through 24 Weeks — 13; 10 Participants — p=0.40
N/A N=9 Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals
HIV
Primary: Global Transcriptome Analysis — 116; 135 genes
Phase 2 N=20 Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy
HIV
Primary: Changes in Gut Microbial Translocation (iFABP) — 145.76; 125.36; 151.5; 111.73 pg/mL
Phase 4 N=16 HIV Persistence and Viral Reservoirs
HIV · HIV Infections
Primary: Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24 — 66 fold decrease in signal/cutoff ratio
N/A N=25 Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy
HIV Infections · AIDS
Primary: the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over…
Phase 4 N=93 Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients
Chronic Diarrhea of Unknown Origin
Primary: Number of Participants With a 50 Percent Decrease in Mean Stool Count — 17 Participants
Phase 4 N=33 Mesalamine to Reduce T Cell Activation in HIV Infection
HIV Infections · Sexually Transmitted Diseases · Immune System Diseases
Primary: Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study — 0.03; -0.01 Log10(percentage of T cells) — p=0.63
Phase 1 N=16 Glutathione and Function in HIV Patients
HIV Infection · Erythrocyte Glutathione Deficiency
Primary: Muscle Glutathione Concentration — 0.5; 2.2 micromol/g.Hb
Phase 2 N=73 Rifaximin as a Modulator of Microbial Translocation and Immune Activation
HIV-1 Infection
Primary: Change in CD8+ T-cell Activation From Baseline to Week 4 — 0.00; 0.64 percentage HLA-DR+/CD38+ of CD8+ — p=0.028
Phase 2 N=33 Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
Anal Cancer · Precancerous Condition
Primary: Proportion of Patients With Regression of Perianal High-grade Squamous Intraepithelial Lesions (HSIL) — 0.515 proportion of participants
N/A N=24 Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome
HIV Infections · Cardiovascular Disease · Insulin Resistance
Primary: Myocardial Glucose Utilization Rate — 109.6; 106.7; 109.1; 87.2 (nmol glucose/g heart muscle/min
N/A N=250 Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients
HIV Infections · Memory
Primary: The Prevalence of Neurocognitive Deficits Among HIV-positive Patients as Defined by the Global Deficit Score Based on the Neuropsychological Testing Battery and to…
N/A N=18 Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
HIV Infections · Lipodystrophy · Metabolic Diseases
Primary: Mitochondrial Function (mtDNA Levels) — 1372 copies per cell
N/A N=214 Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART
HIV Infection
Primary: Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups — 0.19; 0.09 percent change…