An observational study in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by ViiV Healthcare. Completed at 9 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 5th largest by enrollment of the 14 observational ones that give a count, is one of 10 that started in 2017, is one of 14 observational ones, and was the 181st registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 10 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 578 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
Add all 5 to your calendar (.ics) → With an account.
Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence. This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection. Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment. It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
This study's enrollment of 578 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
Compared within HIV Infections, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
This prospective cohort study will involve population of HIV-1 uninfected Chinese MSM and TGW who are at high-risk of HIV infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria:
Subjects in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for >1 year are not eligible for participation.
Exclusion Criteria:
Any of the following laboratory values at screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will involve HIV-1 uninfected high risk MSM and TGW subjects. They will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment. Visits will include Baseline screening for HIV followed by screenings at Day 1, Weeks 5, 9, and 8 week intervals thereafter until study conclusion. Screening for other STIs will occur at Baseline, Week 9, and every 16 weeks thereafter.
Behavioral: Risk reduction counseling · Other: Social harm interview · Other: Computer-Assisted Self Interviewing technique
Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.
HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
HIV-1 seroincidence rate in a cohort of high-risk TGW
Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits. Confirmatory HIV serology test will be performed at seroconversion visit.
Time frame: Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
Infections like gonorrhea, chlamydia, and syphilis will be assessed by toluidine red unheated serum test (TRUST) for syphilis and STI testing.
Time frame: Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
Number of subjects with demographic factors
Demographic factors associated with HIV seroconversion and STI acquisition will be assessed by computer-assisted self-interview (CASI).
Time frame: Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
Number of subjects enrolled and retained in to the study
Measures will be utilized to effectively engage and retain the subjects in the study. Retention strategies to be studied may include community engagement, interpersonal relationship building and reduction of external barriers.
Time frame: Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
Ran from Aug 2017 to primary completion in Dec 2018, 16 months.
Of 201 observational studies under HIV Infections, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.