GS-2872 for HIV Infections

1
Effectiveness
1
Safety
Ruane Clinical Research Group Inc., Los Angeles, CA
HIV Infections+3 More
GS-2872 - Drug
Eligibility
18+
All Sexes
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether a combination of antibodies and a drug may help treat HIV.

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Eligible Conditions

  • HIV Infections
  • Infections
  • Communicable Diseases
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Treatment Effectiveness

Study Objectives

This trial is evaluating whether GS-2872 will improve 1 primary outcome and 27 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of First dose date up to Week 26.

Baseline; Week 26
Change from Baseline in CD4+ Cell Count at Week 26
Baseline; Week 52
Change from Baseline in CD4+ Cell Count at Week 52
Week 52
PK Parameter: AUClast of GS-5423, and GS-2872, and LEN
PK Parameter: AUClast of Teropavimab, and GS-2872, and LEN
PK Parameter: Cmax of GS-5423, and GS-2872, and LEN
PK Parameter: Cmax of Teropavimab, and GS-2872, and LEN
PK Parameter: Ct of GS-5423, and GS-2872, and LEN
PK Parameter: Ct of Teropavimab, and GS-2872, and LEN
PK Parameter: T1/2 of GS-5423, and GS-2872, and LEN
PK Parameter: T1/2 of Teropavimab, and GS-2872, and LEN
PK Parameter: Tlast of GS-5423, and GS-2872, and LEN
PK Parameter: Tlast of Teropavimab, and GS-2872, and LEN
PK Parameter: Tmax of GS-5423, and GS-2872, and LEN
PK Parameter: Tmax of Teropavimab, and GS-2872, and LEN
Pharmacokinetic (PK) Parameter: AUC0-t of GS-5423, and GS-2872, and LEN
Pharmacokinetic (PK) Parameter: AUC0-t of Teropavimab, and GS-2872, and LEN
Proportion of Participants Who Develop Treatment-Emergent Resistance to Lenacapvir (LEN), GS-5423, and GS-2872
Proportion of Participants Who Develop Treatment-Emergent Resistance to Lenacapvir (LEN), Teropavimab, and GS-2872
Week 26
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)
Week 52
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Percentage of Participants Experiencing Treatment-Emergent Severe Adverse Events (SAEs)
Week 26
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Week 52
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Proportion of Participants With Positive Anti-GS-2872 Antibodies
Proportion of Participants With Positive Anti-GS-5423 Antibodies
Proportion of Participants With Positive Anti-Teropavimab Antibodies

Trial Safety

Trial Design

4 Treatment Groups

No Control Group
Lenacapavir (LEN), teropavimab, GS-2872 Dose C

This trial requires 21 total participants across 4 different treatment groups

This trial involves 4 different treatments. GS-2872 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Lenacapavir (LEN), teropavimab, GS-2872 Dose CParticipants will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + GS-2872 Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + GS-2872 Dose C.
LEN, teropavimab, GS-2872 Dose DParticipants will begin treatment by receiving LEN Dose A + LEN Dose B + teropavimab + GS-2872 Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + teropavimab + GS-2872 Dose D.
LEN, GS-5423, GS-2872 Dose DParticipants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose D followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose D.
Lenacapavir (LEN), GS-5423, GS-2872 Dose CParticipants will begin treatment by receiving LEN Dose A + LEN Dose B + GS-5423 + GS-2872 Dose C followed by LEN Dose A on the next day. The last treatment regimen will include LEN Dose B + GS-5423 + GS-2872 Dose C.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to week 52
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 up to week 52 for reporting.

Closest Location

Ruane Clinical Research Group Inc. - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are on first-line ART for ≥ 2 years prior to screening. show original
No documented historical resistance to the current ART regimen
Plasma HIV-1 RNA < 50 copies/mL at screening
Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 18 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable.
You have been exposed to the investigational compound GS-2872. show original
CD4+ count nadir ≥ 350 cells/μL. show original
Screening CD4+ count ≥ 500 cells/μL
Availability of a fully active alternative ART regimen, in the opinion of the investigator, in the event of discontinuation of the current ART regimen with development of resistance. show original
Key

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hiv infections be cured?

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In the developed world, although one in two men is estimated to be cured of HIV, the possibility does not necessarily remain that the HIV infection can be cured. It is important to emphasize the difficulty of achieving and maintaining AIDS-free status, while attempting to maximize the chances for a cure. Failure to maintain effective antiretroviral treatment increases the risk for disease progression, including neurological disease, and may lead to late, often irreversible, neurologic dysfunction. A cure does not necessarily imply remission of HIV infection.

Unverified Answer

What are the signs of hiv infections?

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There are a range of symptoms from HIV infection that can either be specific to an infection with HIV or may be caused by secondary infections, which include opportunistic infections. While a high index of suspicion may be required, a combination of symptoms may be present. Those who have symptoms associated with HIV infection should be referred for laboratory testing.

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What are common treatments for hiv infections?

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The first-line of treatment for HIV-related complications (i.e., antiretroviral therapy) involves medications and behavioural changes, while referral to specialist clinics for a clinical diagnosis of HIV/AIDS should be considered after some time. The use of the newer HAART/combined antiretroviral therapy in the treatment of HIV in Japan is expanding and many institutions are expanding the number of beds to facilitate treatment in the first instance.\n\nThe development of clinical practice guidelines for the treatment of asthma, diabetes and hypertension is essential for improving the treatment protocols.\n\nAlthough many patients who have recurrent chest infection are treated at any step by antibiotics, many of these patients do not require it.

Unverified Answer

What causes hiv infections?

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HIV infections are not caused by a specific disease, but by exposure to blood and semen collected in the course of sexual activity. The disease arises when exposure produces an immune response.\n

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What is hiv infections?

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The HIV can affect the development of certain cancers. HIV is transmitted by close heterosexual contact and use of intravenous drug use. Risk of developing the cancers may be higher in people infected by the virus.

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How many people get hiv infections a year in the United States?

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An estimated 3.5 million new hiv infections are diagnosed in the U.S. each year. theme:

access and cost question: Is treatment with low-dose abiraterone acetate for a long duration of remission in metastatic castration-resistant prostate cancer safe and effective? answer: Low-dose abiraterone acetate provides long-term (62.9 mo) and complete (93%) PSA control in more than 70% of patients with metastatic castration-resistant prostate cancer. Although there are safety concerns, this study suggests that low-dose abiraterone acetate represents the first-line treatment option for patients with metastatic castration-resistant prostate cancer.

Unverified Answer

Have there been any new discoveries for treating hiv infections?

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Findings from a recent study are highly encouraging. In the future, we must make sure that our research is not only used for evaluating the effectiveness of drugs but also in treatment to improve the quality of life of infected patients.

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Is gs-2872 typically used in combination with any other treatments?

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The clinical use of GS-2872 to alter PSA kinetics in HIV+ subjects is relatively limited because of the high levels of viral contamination in a number of clinical studies to date. This may be due to the need for more sensitive assays to monitor therapeutically relevant concentrations of PSA kinetics in these clinical studies, which are often performed at the highest dose (2.5x) of GS-2872 to test for maximal PSA changes.

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Who should consider clinical trials for hiv infections?

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Individuals with HIV infection may not be well-served by the current model of care, and participation in clinical trials has the potential to improve care, improve outcomes, and address the gaps in providers' knowledge and practices about HIV and HIV treatment.

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What is the average age someone gets hiv infections?

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On average men acquire HIV before age 25 but women do not; these data are helpful in developing strategies to reduce the number of new HIV infections and their associated burden of disease.

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Have there been other clinical trials involving gs-2872?

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This is the earliest clinical trial investigating the efficacy and safety of the investigational drug, GS-2872. Results are published on F1000 but not available on ClinicalTrials.gov. If available, a "trial results" page is available at F1000.

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How serious can hiv infections be?

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Serious viral infections, even those without symptoms, are likely to have serious consequences. They should be treated as severely as other viral infections, and precautions taken.

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