Clinical trials: HIV-1
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Safety of an HIV Vaccine (AVX101) in HIV Uninfected Volunteers in the United States and South Africa
The purpose of this study is to see if different doses of an experimental HIV vaccine are safe and to study how the immune system responds to the vaccine. The vaccine will be tested in healthy, HIV uninfected volunteers.
- Trial name
- NCT00063778
- Testing
- AVX101
- Where
- 7 sites in United States, South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaVax, Inc.
HIV Prevention
OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults
This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated…
- Trial name
- NCT04791007
- Testing
- OB-002
- Where
- Poland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Orion Biotechnology Polska Sp. z o.o.
HIV 1 Infection
Dapivirine Gel Rectal Safety and PK Study
Dapivirine Gel Rectal Safety and PK Study
- Trial name
- NCT03044379
- Testing
- Dapivirine gel (0.05%)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active…
- Trial name
- NCT00469170
- Testing
- intravaginal ring
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates.
- Trial name
- NCT03310515
- Testing
- Risk reduction counseling, Social harm interview, Computer-Assisted Self Interviewing technique
- Where
- 9 sites in China
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
Evaluating the Safety and Immunogenicity of Polyvalent DNA/gp120 HIV Vaccine in Healthy, HIV-uninfected Adults
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of polyvalent env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein vaccines (PDPHV201401) co-administered together with or without adjuvant…
- Trial name
- NCT04927585
- Testing
- env (A,B,C,A/E)/gag (C) DNA Vaccine, gp120 (A,B,C,A/E) Protein Vaccine, GLA-SE adjuvant
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Worcester HIV Vaccine
HIV
A Clinical Study of Alimatravir (MK-8527) in Transgender (Trans) and Gender Diverse Individuals on Gender-affirming Hormone Therapy and at Low Likelihood of Human Immunodeficiency Virus (HIV)-1 Exposure (MK-8527-018)
The goal of this study is to learn about the safety of alimatravir (MK-8527) in transgender and gender-diverse people and if they tolerate it.
- Trial name
- EXPrESSIVE-18 (NCT07850609)
- Testing
- Alimatravir
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
- Trial name
- NCT05165550
- Testing
- Elsulfavirine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Viriom
HIV Infections
Assessing the Safety of Dapivirine Gel and Film Formulations
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
- Trial name
- NCT01548560
- Testing
- Dapivirine Vaginal Film, Dapivirine Vaginal Gel
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1-infection, Hepatic Impairment
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the…
- Trial name
- NCT03706898
- Testing
- Elpida®, Dolutegravir, Sofosbuvir
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Viriom
HIV-1, HIV Infections
A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)
This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10^9 viral particles/dose (vp/d) or placebo.
- Trial name
- NCT00849732
- Testing
- V520, Comparator: V520 (1x10^9 vp/d), Comparator: V520 (1x10^10 vp/d)
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender Individuals
The purpose of this study is to evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection…
- Trial name
- MOSAICO (NCT03964415)
- Testing
- Ad26.Mos4.HIV, Clade C and Mosaic gp140 HIV bivalent vaccine
- Where
- 53 sites in United States, Argentina and 7 more
- Volunteers
- 3,900 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Pre-Exposure Prophylaxis of HIV-1 Infection
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or…
- Trial name
- DISCOVER (NCT02842086)
- Testing
- F/TAF, F/TDF
- Where
- 93 sites in United States, Austria and 9 more
- Volunteers
- 5,399 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
HIV-1 Infection
Islatravir and Methadone Pharmacokinetics (MK-8591-029)
The present study is designed to determine the effect of islatravir (ISL) [MK-8591] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve…
- Trial name
- NCT04568603
- Testing
- Islatravir
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1, HIV Infections
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared…
- Trial name
- NCT00849680
- Testing
- Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal…
- Trial name
- NCT00613249
- Testing
- Dapivirine Gel 4750, 0.05%, 2.5g, Dapivirine Gel 4789, 0.05%, 2.5g
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.