A clinical trial is always designed to gain some knowledge about something not yet well-known, or proven. A person may volunteer to participate in a clinical study for various reasons. Frequently a physician may recommend a patient to consider volunteering for specific study participation, as part of the patient therapeutic treatment options. Clinical trials are highly regulated, and are conducted following strict scientific standards in order to protect patients and to produce meaningful results. There are important facts a person should know about participation in a clinical study, including:

Different types of studies (Phase 1 to Phase 4)
What a volunteer should expect before and during the participation on a clinical trial?
What is an informed-consent and why is needed?
Risks and benefits of participating in a study
Questions that a person should consider asking before volunteering

The information contained here is mainly related to clinical interventional studies (also called protocols), which are studies in which participants are given a study medication, and then are followed over a period of time. We are also focusing this information on issues that are relevant to the studies that we conduct at the Midway Research Center. To obtain more information about clinical studies in general, please visit Clinical Trials.gov, a service provided by the NIH (National Institute of Health).

Trials to Date

AIC316-03-11-01

Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Adults (PRIOH-1)

Key Inclusion Criteria

1. Must be immunocompromised (HIV, organ transplant, chronic steroid use, etc.)
2. HSV lesion with clinical failure 5 days after using acyclovir, valacyclovir, or famciclovir.
3. HSV lesion accessible for size measurement and photography

PRO140_CD02 Open Label

A Multi-center, Two-Part, Single-Arm, Open Label, 25-Week Trial with PRO 140 in Treatment-Experienced HIV-1 Subjects

Main Inclusions

1. Exclusive CCR5-Tropic virus
2. 3 Months on current ART
3. 3 Drug-class resistance or 2 drug class with another drug class intolerance
4. HIV RNA >= 400
5. Has to have at least one viable option for OBT

GS-US-380-4458

Safety and Efficacy of Bictegravir/Emtricitabine/ Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (Alliance)

Major Inclusion Criteria

1. Naïve to ART (<10 days of prior ART)
2. Hepatitis B Co-infection
3. GFR >= 50
4. Negative for HCV RNA

GS-US-380-4580

Phase 3b, Multicenter, Open-label Study to Evaluate Switching From a Regimen of 2 NRTIs plus a 3rd Agent to a Fixed Dose Combination of Biktarvy in Virologically-Suppressed, HIV-1 Infected African American Subjects.

Major Inclusion Criteria

1. Self-describes as Black, African American, or mixed race including Black
2. 3 Drug Regimen including 2 NRTIs for > 6 months
3. HIV RNA < 50 for > 6 months
4. No documented or suspected INSTI resistance

GS-US-200-4072

Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Adults

Major Inclusion/Exclusion Criteria

1. HIV Naïve or off ART for > 12 weeks
2. Integrase Naive
3. HIV RNA > 10,000 but < 400,000 copies
4. Absolute CD4 > 200
5. GFR > 70
6. Willing to start Biktarvy on day 10
7. No medications taken within 42 days prior to start of the study drug without prior approval from Sponsor

ABT-3BNC117-201

Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects (ABL)

Major Inclusion/Exclusion Criteria

1. HIV RNA < 50 for 6 months
2. On ART for > 24 weeks, NNRTI regimens are not allowed – they can be changed at or before screening to PI or INSTI
3. Absolute CD4 > 300
4. Excludes HBV and HCV
5. No vaccinations within 2 weeks prior to first study dose

SMT19969/C004

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)

Major Inclusion/Exclusion Criteria

1. Have S/S of CDI with >= 3 UBMs 24 hour prior to randomization
2. Presence of either toxin A and/or B determined by a + free toxin test (stool must be produced 72H prior to randomization.
3. Can not have more than 1 prior episode of CDI in previous 3 months or more than 3 episodes in last 12 months
4. Can not have history of chronic diarrheal disease (IBS, Crohn’s Ulcerative Colitis, etc.)
5. Less than 24 hours of dosing with CDI ABX (4 vanco, 2 fidaxomicin, or 3 flagyl)

1	Recruiting	Evaluate the Safety and Efficacy of Vesatolimod in Antiretroviral Treated HIV-1 Infected Controllers	HIV-1 Infection	Drug: Vesatolimod; Drug: Vesatolimod Placebo; Drug: ART
2	Recruiting	A Randomized, Double-blind, Placebo-controlled Trial, Followed by Single-arm Treatment of PRO 140 in Combination w/ Optimized Background Therapy in Treatment-Experienced HIV Subjects	HIV	Drug: PRO 140; Drug: Placebo; Drug: Optimized Background Regimen
3	Recruiting	Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff	Clostridium Difficile Infection Recurrence	Drug: Full Spectrum Microbiota; Drug: Placebo
4	Completed Has Results	Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	HIV; HIV Infections	Drug: Stribild; Drug: Atripla; Drug: Stribild Placebo; Drug: Atripla Placebo
5	Completed Has Results	Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	HIV-1 Infection	Drug: FTC/RPV/TDF; Drug: EFV/FTC/TDF
6	Active, not recruiting Has Results	Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants	HIV; HIV Infections	Drug: E/C/F/TAF; Drug: E/C/F/TDF; Drug: EFV/FTC/TDF; Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI
7	Completed	Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus	HIV-1 Infection	Drug: Cenicriviroc 100 mg; Drug: Cenicriviroc 200 mg + Truvada; Drug: Sustiva + Truvada
8	Completed Has Results	A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.	Hepatitis C	Drug: Daclatasvir; Drug: Sofosbuvir
9	Completed Has Results	Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF	HIV-1 Infection	Drug: FTC/RPV/TDF; Drug: PI; Drug: RTV; Drug: NRTIs
10	Completed Has Results	Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients	Acquired Immunodeficiency Syndrome; HIV Infections	Drug: NNRTI; Drug: FTC/TDF; Drug: Stribild
11	Completed Has Results	Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults	HIV; HIV Infections; Acquired Immunodeficiency Syndrome	Drug: TAF; Drug: Placebo; Drug: E/C/F/TAF; Drug: Current failing ARV regimen; Drug: ATV
12	Completed Has Results	Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults	HIV; HBV	Drug: E/C/F/TAF
13	Completed Has Results	Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	HIV; HIV Infections	Drug: Stribild; Drug: ATV; Drug: Ritonavir; Drug: FTC/TDF; Drug: Stribild Placebo; Drug: ATV Placebo; Drug: RTV Placebo; Drug: FTC/TDF Placebo
14	Completed Has Results	Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment	Acquired Immunodeficiency Syndrome; HIV Infections	Drug: E/C/F/TDF; Drug: COBI; Drug: ATV; Drug: DRV; Drug: NRTI
15	Active, not recruiting	Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults	HIV-1 Infection	Drug: FTC/RPV/TAF; Drug: EFV/FTC/TDF Placebo; Drug: EFV/FTC/TDF; Drug: FTC/RPV/TAF Placebo
16	Active, not recruiting	Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)	HIV-1 Infection	Drug: FTC/RPV/TAF; Drug: FTC/RPV/TDF Placebo; Drug: FTC/RPV/TDF; Drug: FTC/RPV/TAF Placebo
17	Active, not recruiting Has Results	Safety and Efficacy of E/C/F/TDF (Stribild®) Versus RTV-Boosted ATV Plus FTC/TDF (Truvada®) in HIV-1 Infected, Antiretroviral Treatment-Naive Women	Acquired Immunodeficiency Syndrome; HIV Infections	Drug: E/C/F/TDF; Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: E/C/F/TDF Placebo; Drug: RTV Placebo; Drug: ATV Placebo; Drug: FTC/TDF Placebo; Drug: E/C/F/TAF
18	Not yet recruiting	Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis	Infective Endocarditis, Bacteremia	Drug: Dalbavancin; Drug: Standard of Care
19	Completed Has Results	Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults	HIV-1; HIV Infections; Acquired Immunodeficiency Syndrome	Drug: E/C/F/TAF; Drug: DRV; Drug: Baseline DRV- containing ARV regimen
20	Active, not recruiting Has Results	Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment	HIV; HIV Infections	Drug: E/C/F/TAF
21	Completed	Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV	HIV	Biological: ibalizumab; Drug: Optimized Background Regimen (OBR)
22	Completed Has Results	Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	HIV; HIV Infections	Drug: COBI; Drug: RTV; Drug: ATV; Drug: FTC/TDF; Drug: COBI placebo; Drug: RTV placebo
23	Recruiting	Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed	HIV-1-infection	Drug: B/F/TAF; Drug: F/TAF; Drug: DTG; Drug: DTG Placebo; Drug: F/TAF Placebo; Drug: B/F/TAF Placebo
24	Active, not recruiting Has Results	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	HIV; HIV Infections	Drug: E/C/F/TAF; Drug: E/C/F/TDF; Drug: E/C/F/TDF Placebo; Drug: E/C/F/TAF Placebo
25	Recruiting	Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Adults	HSV Infection	Drug: Pritelivir; Drug: Foscarnet
26	Recruiting	Study of PRO 140 SC as Single Agent Maintenance Therapy in Virally Suppressed Subjects With CCR5-tropic HIV-1 Infection	HIV	Drug: PRO 140
27	Recruiting	A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care	HIV-1	Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
28	Recruiting	Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adults Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I	HIV-1 Infection	Drug: E/C/F/TAF
29	Active, not recruiting	Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis	HIV-1 Infection	Drug: E/C/F/TAF
30	Completed Has Results	Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults	Acquired Immunodeficiency Syndrome; HIV Infections	Drug: COBI; Drug: DRV; Drug: NRTIs
31	Active, not recruiting Has Results	Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults	HIV; HIV Infections	Drug: E/C/F/TAF; Drug: E/C/F/TDF; Drug: E/C/F/TDF Placebo; Drug: E/C/F/TAF Placebo
32	Active, not recruiting Has Results	Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF	HIV-1 Infection	Drug: FTC/TDF; Drug: F/TAF; Drug: Allowed third antiretroviral agent; Drug: FTC/TDF Placebo; Drug: F/TAF Placebo
33	Active, not recruiting	Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC	HIV-1 Infection	Drug: F/TAF; Drug: ABC/3TC; Drug: ABC/3TC Placebo; Drug: F/TAF Placebo; Drug: Third antiretroviral agent
34	Active, not recruiting	Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults	HIV-1 Infection	Drug: E/C/F/TAF; Drug: ABC/3TC; Drug: Third Antiretroviral Agent
35	Completed Has Results	Phase 3 Study of Sofosbuvir and Ribavirin	Hepatitis C	Drug: Sofosbuvir; Drug: PEG; Drug: RBV
36	Active, not recruiting	Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment	HIV-1 Infection; HCV Infection	Drug: E/C/F/TAF; Drug: F/R/TAF; Drug: LDV/SOF