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HOPE II Study

Human Papillomavirus One-Dose-vaccine Prevention Efficacy among Women Living with HIV (HOPE II) Study Study Rationale The HOPE II Study aims to explore whether a single-dose HPV

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What is this study about?

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FAQs

What is HPV?

Human papillomavirus (HPV) is a virus which is spread mainly through sexual activity. Most people with HPV don’t know they have it because it often doesn’t cause any symptoms. In many cases, the body’s immune system can fight off the virus, and it goes away on its own.

What is the HPV Vaccine?

There are vaccines available that can protect against the most dangerous types of HPV, and they are recommended for girls and women aged 9-45 years. The vaccine can also prevent HPV infection in men.

Why is this study being done?

This study wants to find out if one shot of the HPV vaccine is enough to protect girls and women living with HIV from getting HPV and cervical cancer, or if they need more than one shot

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WONDERS 2 Study

Exploring a Once-Weekly HIV Treatment Option The WONDERS 2 Study is a Phase 2/3 clinical trial being conducted by Wits RHI to assess the safety and efficacy of a novel once-weekly oral HIV-1 treatment regimen in people who have never received antiretroviral therapy (ART). The study evaluates whether a combination of GS-1720 (an integrase strand-transfer inhibitor) and GS-4182 (a lenacapavir prodrug) can be a viable alternative to daily HIV treatment.

M72 TB Vaccine Study

This is a Phase 3, randomized, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy, safety, and immunogenicity of the investigational M72/AS01E-4

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HOPE II Study

Human Papillomavirus One-Dose-vaccine Prevention Efficacy among Women Living with HIV (HOPE II) Study Study Rationale The HOPE II Study aims to explore whether a single-dose HPV

Download PDF

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What is this study about?

The primary objective of this study is to determine whether the combination of 3BNC117-LS-J and 10-1074-LS-J can effectively maintain viral suppression in people living with HIV while pausing ART, provided the bNAbs remain at therapeutic levels. The study will assess both the safety and efficacy of this innovative treatment strategy, which could represent a significant advancement in HIV management if proven effective.

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What is the treatment regime?

Participants will be randomized in a 2:1 ratio to receive either the study investigational product (Arm A) or placebo (Arm B) and will discontinue ART 2 days later.

Arm A: 32 participants will receive a single intravenous infusion of 3BNC117-LS-J (30 mg/kg) and a single intravenous infusion of 10-1074-LS-J (10 mg/kg).

Arm B: 16 participants will receive a single intravenous infusion of Placebo for 3BNC117-LS-J (0.9% Sodium Chloride Injection) and a single intravenous infusion of Placebo for 10-1074-LS-J (0.9% Sodium Chloride Injection).

What are the primary and secondary objectives?

Primary objectives

To evaluate the safety and tolerability of intravenous infusions of 3BNC117-LS-J and 10-1074- LS-J in virally suppressed adults with HIV in sub-Saharan Africa.
To evaluate the efficacy of the combination of 3BNC117-LS-J and 10-1074-LS-J versus placebo in preventing the return of sustained HIV-1 viremia (confirmed HIV-1 viral load >200 copies/mL) for 24 weeks after ART discontinuation in adults with HIV who have maintained viral suppression prior to the analytical treatment interruption (ATI) in sub-Saharan Africa.

Secondary Objectives

To evaluate the efficacy of the combination of 3BNC117-LS-J and 10-1074-LS-J versus placebo in maintaining plasma HIV-1 RNA levels <50 copies/mL for 24 weeks after ART discontinuation in people/participants living with HIV (PWH) who have maintained viral suppression prior to the ATI.
To evaluate the efficacy of the combination of 3BNC117-LS-J and 10-1074-LS-J in preventing the return of sustained HIV-1 viremia (confirmed HIV-1 viral load >200 copies/mL) while serum concentration of each bNAb remains ≥10 mcg/mL after ART discontinuation in PWH who have maintained viral suppression prior to the ATI.
To evaluate the efficacy of the combination of 3BNC117-LS-J and 10-1074-LS-J in preventing the return of sustained HIV-1 viremia (confirmed HIV-1 viral load >200 copies/mL) for 24 weeks after serum concentration of each bNAb declines to <10 mcg/mL after ART discontinuation in PWH who have maintained viral suppression prior to the ATI.
To evaluate the pharmacokinetic (PK) parameters of the combination of 3BNC117-LS-J and 10-1074-LS-J during ATI in PWH in sub-Saharan Africa.
To estimate the minimum effective concentrations of bNAbs required to maintain viral suppression.
To evaluate evidence of anti-drug antibodies (ADA) against 3BNC117-LS-J and/or 10-1074-LS-J in samples collected at selected time points throughout the study.
To evaluate the effects of the combination of 3BNC117-LS-J and 10-1074-LS-J on CD4+ T-cell count after ART discontinuation in adults with HIV who have maintained viral suppression prior to the ATI.

Why is this study being done?

This study wants to find out if one shot of the HPV vaccine is enough to protect girls and women living with HIV from getting HPV and cervical cancer, or if they need more than one shot.

HPV (human papilloma virus) causes about 80% of cervical cancer cases. It can infect the private parts and cause warts (small skin bumps), and in some cases, it can lead to cancer. The HPV vaccine helps stop the virus from infecting the cervix. In South Africa, the Department of Health offers the HPV vaccine to girls in grade 5 who are 9 years or older. Right now, one dose of the HPV vaccine is recommended for girls and boys between 9 and 20 years old to help prevent cervical cancer. But girls and women living with HIV were not part of the studies that led to this advice. This new study will help us learn more about how well the vaccine works for them.

What is this study about?

Download the brochure

Download PDF

FAQs

What is HPV?

What is the HPV Vaccine?

There are vaccines available that can protect against the most dangerous types of HPV, and they are recommended for girls and women aged 9-45 years. The vaccine can also prevent HPV infection in men.

Why is this study being done?

This study wants to find out if one shot of the HPV vaccine is enough to protect girls and women living with HIV from getting HPV and cervical cancer, or if they need more than one shot

HOPE II Study

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