CLINICAL TRIAL

pgDC + conserved HIV peptides for HIV Infections

Recruiting · 18+ · All Sexes · Columbus, OH

This study is evaluating whether a vaccine made from a person's own white blood cells may help prevent HIV.

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About the trial for HIV Infections

Treatment Groups

This trial involves 6 different treatments. PgDC + Conserved HIV Peptides 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.

Experimental Group 1
pgDC + conserved HIV peptides
BIOLOGICAL
Experimental Group 2
a1DC + inactivated whole autologous HIV
BIOLOGICAL
Experimental Group 3
pgDC + inactivated whole autologous HIV
BIOLOGICAL
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have been taking continuous ART for at least 24 months (defined as no interruptions longer than 14 consecutive days) and with no changes in the components of the ART for at least 8 weeks prior to study entry are eligible to participate in this study show original
In order to qualify for this study, participants must have a plasma HIV-1 RNA level of less than 50 copies/ml using a FDA-approved assay for at least 24 months prior to study entry show original
The participant's ability and willingness to provide informed consent is questioned. show original
Based on the investigator's assessment, there are no medical, mental health, or other conditions that would prevent the person from participating in the study. show original
Testing for HIV-1 RNA levels using a certified assay performed by a qualified laboratory within the past 60 days in order to be allowed into the country. show original
People aged 18 to 65. show original
Bilirubin ≤1.5 x ULN A person's blood is considered healthy if their hemoglobin levels are above 10 grams per deciliter, their absolute neutrophil count is above 1000/mm3, their platelet count is above 100,000/mm3, their creatinine levels are below 1.5x the upper limit of normal, their aspartate aminotransferase and alanine aminotransferase levels are below 2.5x the upper limit of normal, and their bilirubin levels are below 1.5x the upper limit of normal. show original
If a person's HIV-1 RNA level is more than 50 copies/ml but less than 200 copies/ml, they are allowed to have a subsequent value that is less than 50 copies/ml. show original
HIV-1 infection, whether or not it is documented by an FDA-approved assay. show original
The text is saying that the study participants need to have a CD4+ cell count of 350 or more cells/mm3 within 60 days of the study entry. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80
Screening: ~3 weeks
Treatment: Varies
Reporting: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Step 2-Week 0 (overall Study Week 12) to overall Study Week 80.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether pgDC + conserved HIV peptides will improve 2 primary outcomes and 6 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Baseline to Step 2-Week 22 (overall Study Week 34).

Effect of DC-HIV vaccination on the levels of systemic inflammation
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Changes in soluble markers of systemic inflammation and assessment of the differences between the vaccine arms
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Effect of DC-HIV vaccination on the levels of immune activation
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Changes in markers of cellular immune cell activation and assessment of the differences between the vaccine arms
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Relative efficacy of the DC-HIV vaccines in priming HIV-specific-CD8+ T cells
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Change in the ability of the DC-HIV vaccines to inhibit autologous HIV in an ex vivo virus inhibition assay.
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Assess the impact of DC-HIV vaccination on levels of cell-associated HIV-1 RNA and DNA
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Changes in cell-associated HIV-1 RNA and DNA levels and assessment of the differences between the vaccine arms
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Efficacy of six immunizations (10e7 DCs per dose) of DC-whole virus and DC-peptide vaccines in HIV-1 infected participants on effective ART
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Change in HIV-specific CD8 and T-cell immune response as measured by ELISPOT between the vaccine arms.
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Effect of DC-HIV vaccination on HIV specific CD8 T-cell polyfunctional responses
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
Change in HIV specific CD8 T-cell polyfunctional responses as measured by intracellular cytokine staining using flow cytometry.
BASELINE TO STEP 2-WEEK 22 (OVERALL STUDY WEEK 34)
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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?

There is a reasonable chance of curing an asymptomatic HIV infection with treatment. Patients who have a weak immune system or viral load close to the current detection limit may have a greater chance of achieving a sustained viral suppression.

Anonymous Patient Answer

What are common treatments for hiv infections?

Antivirals may be effective in reducing viral load and therefore delaying further disease progression. Nucleoside reverse transcriptase inducers can reduce the duration of symptoms by two to three times. Antihypertensives can improve neurological and cardiac complications. There are few treatments for neurocognitive deficits in HIV infections, but medications such as memantine and diazepam appear to be of value. Antiparasitic medications are of no clinical benefit.\n

Anonymous Patient Answer

What is hiv infections?

There are several risk factors associated with the acquisition of HIV infection, including sex with an HIV infected individual, prior sexual experience, incarceration, unemployment, poverty, incarceration and injecting drug use. Most HIV infections are acquired through heterosexual sex. Most men who have sex with men (MSM) acquire HIV through this route. HIV infection is currently more common in the MSM than in the general population. The US currently has the highest prevalence rate of HIV among women, accounting for 40% of cases. However, the incidence rate is one of the lowest, accounting for only 1.5% of cases.

Anonymous Patient Answer

What are the signs of hiv infections?

At first glance, HIV cases often appear as in people suffering from the common infections of the time. However, an HIV diagnosis should be suspected if the following conditions are present: fever with low white cell counts at presentation, weight fall, swollen lymph nodes, high blood levels of lumps and/or spirochetes, or abnormal blood values. This diagnosis must be supported in cases where the duration and severity of the complaint is atypical, in cases where the history remains ambiguous, or where the clinical picture is otherwise unusual. In such instances, close, careful observation with the aid of modern diagnostic tests and consideration of the patient's exposure history is required.

Anonymous Patient Answer

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

From 1986 to 2004, an estimated 3,917,964 new and established cases of HIV infection have occurred, with a ratio of men to women 1:1.7, a national estimated prevalence of 6.3 percent, and an incidence of 3.2 infections/100,000 population. Although the incidence of infection continues to decline, the prevalence is expected to peak in 2010-2020 at a higher value, at 7.8 percent. For this reason, the number of new total cases in the United States is expected to reach an absolute value of 5.4 million in 2022. For these reasons, the US epidemic is expected to continue for the next 15+ years.

Anonymous Patient Answer

What causes hiv infections?

[Infections caused by HIV-1 in the bloodstream have been reported for decades; most patients presented with acute illness with few symptoms. Patients with CD4 cell counts of 800 to 1,200 are common. The diagnosis of acute viral pneumonia with or without radiological evidence of infection is usually made, but diagnosis of acute HIV infection has rarely been considered even after a negative pulmonary test.] It also is the preferred term for such conditions in Latin America. [The definition of AIDS as a clinical disorder includes the possibility of impending, as well as current, infection(s). For this reason, some clinicians in the United States and Cuba view AIDS as a collection of syndromes rather than as a disease of the immune system.

Anonymous Patient Answer

Does hiv infections run in families?

[Hormone replacement therapy (HRT) and a history of premature ovarian failure (POF) are familial risk factors for menopause. Genetic factors are also probably involved in the onset of osteoporosis and other age-related diseases (ORMD) of the skeleton, as well as in prostate cancer and breast cancer (BRCA 1 and BRCA 2 genes.

Anonymous Patient Answer

How does pgdc + conserved hiv peptides work?

In a recent study, findings demonstrate that D1 is dispensable for efficient presentation of a conserved peptide for T cell responses, while D2 does not play an important role in D1 mediated epitope presentation. In addition, the CTL response towards conserved peptide of gp41 is not dependent on the expression of gp41 on the surface of the DCs.

Anonymous Patient Answer

Has pgdc + conserved hiv peptides proven to be more effective than a placebo?

Results from a recent clinical trial suggest that the effectiveness of these peptides is not due to a Pgp inhibition or a combination effect. However, the results should be interpreted with caution. Nevertheless, further studies with more subjects are required to confirm these finding.

Anonymous Patient Answer

What does pgdc + conserved hiv peptides usually treat?

The absence of clinical benefit with the peptide vaccinations in this trial questions the current use of the peptides to mimic epitopes present within a variety of conserved HIV-1 and HIV-2 epitopes. A more effective vaccine delivery system may be necessary to activate an immune response against these conserved epitopes. The authors also conclude that further studies are needed to determine the mechanisms of the observed clinical response to pGc and pCons peptides.

Anonymous Patient Answer

What is the average age someone gets hiv infections?

The average age for people receiving their first HIV diagnosis in New York state was 27 years, which is much older than the national average of 16 years. This may be because of the large number of young women and Hispanic and African-American men who are infected with HIV in New York who are not being tested at risk.

Anonymous Patient Answer

What are the latest developments in pgdc + conserved hiv peptides for therapeutic use?

Recently, in spite of continuing development of proteome-wide libraries of candidate pgdc + peptides derived from conserved proteins, the therapeutic use of peptides is still limited. It seems that a further progress in the discovery and functional analysis of pgdc + peptides should be expected in the near future.

Anonymous Patient Answer
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