Clinical trials: HIV Negative
HIV
DDI Potential: Dapivirine Vaginal Ring and Miconazole Nitrate
This trial will investigate the potential drug-drug interaction between dapivirine vaginal Ring-004 and vaginally administered miconazole nitrate, and will evaluate the safety of co-administration of the dapivirine vaginal ring…
- Trial name
- NCT01731574
- Testing
- dapivirine, miconazole
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring
The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to…
- Trial name
- NCT01144676
- Testing
- dapivirine
- Where
- Belgium
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each…
- Trial name
- NCT00469768
- Testing
- dapivirine reservoir intravaginal ring, dapivirine matrix intravaginal ring
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied…
- Trial name
- NCT00304642
- Testing
- dapivirine (TMC120) vaginal gel
- Where
- South Africa
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Tuberculosis, Healthy
Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.
The purpose of this study is to test the safety and immunogenicity of MTBVAC as a potential substitute for BCG vaccination. BCG vaccination has indeed demonstrated its major limitation in inducing protection against tuberculosis…
- Trial name
- MTBVAC (NCT02013245)
- Testing
- MTBVAC live vaccine, Commercially available BCG live vaccine
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
HIV Prevention
To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
- Trial name
- NCT02862171
- Testing
- Dapivirine Vaginal Ring-004
- Where
- 6 sites in South Africa, Uganda
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Pharmacokinetics
Expanded Use PK of Dapivirine Vaginal Ring
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
- Trial name
- NCT01952561
- Testing
- dapivirine ring
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection
At the end of 2004 there were more than 40 million people infected worldwide with HIV, with an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2004).
- Trial name
- NCT00386633
- Testing
- MVA-mBN32
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
HIV
A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004…
- Trial name
- NCT02858024
- Testing
- Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons, Dapivirine Vaginal Ring-004 with no menses
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Malaria, Malaria,Falciparum
Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative…
- Trial name
- NCT03420053
- Testing
- PfSPZ Vaccine, PfSPZ Challenge
- Where
- Tanzania
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
HIV- Prevention
To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
A Study to assess the drug-drug interaction potential, between Dapivirine Vaginal Ring-004, containing 25 MG of Dapivirine.
- Trial name
- NCT02847286
- Testing
- Dapivirine Ring-004, Dapivirine Ring-004 for 28 days along with clotrimazole, Clotrimazole
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV
Interaction Between Etravirine or Darunavir/Ritonavir and Artemether / Lumefantrine
The purpose of this study is to investigate the pharmacokinetic interaction between etravirine and artemether/lumefantrine and darunavir/ritonavir and artemether/lumefantrine in healthy Human Immunodeficiency Virus…
- Trial name
- DDI Coartem (NCT01876966)
- Testing
- Etravirine, Darunavir/ritonavir, artemether/lumefantrine
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
HIV Infections, HIV Seronegativity
Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
- Trial name
- NCT00002231
- Testing
- APL 400-003
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth-Lederle Vaccines
HIV Infections, Gonorrhea
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydial Infections, Genital Herpes
- Trial name
- NCT00262106
- Testing
- PRO 2000/5
- Where
- 6 sites in South Africa, Tanzania and 2 more
- Volunteers
- 9,404 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
HIV Infections
A Safety Study of Dapivirine Vaginal Ring in Africa
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.
- Trial name
- NCT01071174
- Testing
- Dapivirine
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections, HIV-1
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium
Approximately 36 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo.
- Trial name
- NCT00309205
- Testing
- dapivirine (TMC120) vaginal gel
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
HIV Infections
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa
Approximately 42 HIV-negative women, aged >18 and < 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo.
- Trial name
- NCT00304668
- Testing
- dapivirine (TMC120) vaginal gel
- Volunteers
- healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV-1 Infections
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo…
- Trial name
- NCT00799058
- Testing
- dapivirine 4789, dapivirine gel 4759
- Where
- 5 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.