What side effects are associated with this type of intervention?

Common treatments for HIV, particularly antiretroviral therapies (ART), are associated with a range of side effects. Stavudine-based regimens often lead to lipodystrophy (fat redistribution), while Zidovudine can cause anemia and gastrointestinal issues. Tenofovir is generally better tolerated but can still cause renal toxicity and bone density loss. Overall, ART can lead to metabolic complications, gastrointestinal disturbances, and, in some cases, severe hypersensitivity reactions. These side effects necessitate careful monitoring and management to ensure patient adherence and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV-1, including nine drugs with pediatric indications approved before 2013. These drugs include various classes such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). Examples include zidovudine (an NRTI), efavirenz (an NNRTI), lopinavir/ritonavir (a PI combination), and dolutegravir (an INSTI). These drugs have been evaluated for their safety, tolerability, and efficacy in both adult and pediatric populations.

What other types of research exist?

ABX464 is a promising novel alternative to STP0404 for HIV patients. It has demonstrated a sustained antiviral effect in a humanized mouse model and is considered an important new addition to the anti-HIV arsenal.

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Integrase Inhibitor

STP0404 for HIV

Q: What is the mechanism of action of this treatment?

Common treatments for HIV, such as antiretroviral therapy (ART), involve a combination of drugs that target different stages of the HIV life cycle. These include reverse transcriptase inhibitors, which prevent the virus from converting its RNA into DNA; protease inhibitors, which block the virus from maturing and becoming infectious; integrase inhibitors, which stop the virus from integrating its DNA into the host's genome; and entry inhibitors, which prevent the virus from entering host cells. These mechanisms are vital for HIV patients as they help to reduce the viral load, improve immune function, and prevent the progression to AIDS, thereby enhancing the quality of life and life expectancy.

Phase 2

Recruiting

Research Sponsored by ST Pharm Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 2, day 4, day 7, day 10, day 11

Summary

This trial tests a new drug called STP0404 to see if it can help people with HIV-1 who haven't had any treatment yet. The study will check if the drug can lower virus levels in the body and if it is safe and well-tolerated by patients.

Who is the study for?

This trial is for adults who have been diagnosed with HIV-1 and haven't started any antiretroviral therapy. People who've had PrEP or PEP (except monoclonal antibodies and INSTI like cabotegravir) can join if they stopped these treatments at least 8 weeks before screening.

What is being tested?

The study tests the effects of different doses of a new drug called STP0404 (Pirmitegravir) against a placebo in people with HIV-1. It aims to see how well the drug works, its safety, how it's tolerated by patients, and how it moves through the body.

What are the potential side effects?

Possible side effects from STP0404 are not detailed but may include typical reactions to antiviral drugs such as headaches, nausea, fatigue, and potential liver toxicity. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 2, day 4, day 7, day 10, day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 2, day 4, day 7, day 10, day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 4, day 7, day 10, day 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV-1 RNA copies change in plasma

Total Number of Adverse Events (AEs) occurring through Day 11

Total Number of Serious Adverse Events (SAEs) occurring through Day 11

Secondary study objectives

Number of participants with HIV-1 RNA <400 copies/mL

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3 STP0404Experimental Treatment1 Intervention

Group II: Cohort 2 STP0404Experimental Treatment1 Intervention

Group III: Cohort 1 STP0404Experimental Treatment1 Intervention

Group IV: Cohort 3Placebo Group1 Intervention

Group V: Cohort 2Placebo Group1 Intervention

Group VI: Cohort 1Placebo Group1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV, such as antiretroviral therapy (ART), involve a combination of drugs that target different stages of the HIV life cycle. These include reverse transcriptase inhibitors, which prevent the virus from converting its RNA into DNA; protease inhibitors, which block the virus from maturing and becoming infectious; integrase inhibitors, which stop the virus from integrating its DNA into the host's genome; and entry inhibitors, which prevent the virus from entering host cells. These mechanisms are vital for HIV patients as they help to reduce the viral load, improve immune function, and prevent the progression to AIDS, thereby enhancing the quality of life and life expectancy.

Evaluating fostemsavir as a therapeutic option for patients with HIV.New Antiretroviral Treatment for HIV.[Resistance to antiretroviral therapy].