CLINICAL TRIAL

elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy for Infections

Waitlist Available · 18+ · All Sexes · Harare, Zimbabwe

This study is evaluating whether starting antiretroviral therapy (ART) early in those recently or acutely infected with HIV-1 affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection.

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About the trial for Infections

Eligible Conditions
Communicable Diseases · Human Immunodeficiency Virus Type 1 (HIV-1) Infection · Infections

Treatment Groups

This trial involves 5 different treatments. Elvitegravir/cobicistat/emtricitabine/tenofovir Alafenamide Or Other Medically-appropriate FDA-approved Antiretroviral Therapy is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
DRUG
Experimental Group 2
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
DRUG
Experimental Group 3
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
DRUG
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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:
The ability and willingness to initiate ART at enrollment is an important factor for successful ART programmes. show original
If you are getting an HIV-1 RNA result, it must be from an FDA-approved or CE-marked assay. show original
Since characterization of Fiebig stage using samples at the time of ART initiation was performed with results known within 12 weeks based on standardized, centralized testing, an estimated Fiebig group at enrollment based on inclusion criteria as shown in the table above will provide additional real-time monitoring for accruals into each study group show original
The ability and willingness of the candidate to provide written informed consent is essential. show original
Female candidates of reproductive potential who are not pregnant and will not become pregnant during the study must agree not to participate in the conception process, and if participating in sexual activity that could lead to pregnancy, the female candidate must agree to use at least one reliable form of contraception while receiving study-provided treatment. show original
A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study entry AND a negative/indeterminate WB or negative/indeterminate Geenius HIV-1/HIV-2 Supplemental Assay within 7 days prior to entry OR A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to study entry AND a documented reactive HIV-1 antibody or positive WB that is negative for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band within 7 days prior to entry OR ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry OR ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND a known prior S/CO <0.5 within 90 days prior to entry OR ARCHITECT or GSCOMBO S/CO >0.5 but <10 within 7 days prior to entry AND a non-reactive HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days prior to entry
The candidate has experienced menarche. show original
The candidate has not had bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. show original
The candidate has not experienced menopause, which is defined as the lack of menstruation within the preceding 12 months. show original
Subjects must be available for study visits at the study site for up to 72 weeks. 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: 48 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 48 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy will improve 2 primary outcomes and 6 secondary outcomes in patients with Infections. Measurement will happen over the course of At week 0.

Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
AT WEEK 0
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
AT WEEK 0
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
AT 48 WEEKS
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
AT 48 WEEKS
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
AT WEEK 48
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
AT WEEK 48
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
AT WEEK 48
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
AT WEEK 48
Cell-associated HIV-1 RNA in 5 million blood-derived CD4+ T-cells assayed by qPCR
48 WEEKS
Assess cell-associated HIV-1 RNA per 5 million CD4+ T-cells assayed by qPCR prior to ART initiation and while HIV-1 RNA is suppressed on ART
48 WEEKS
Cell-associated HIV-1 RNA/DNA ratio in 5 million blood-derived CD4+ T-cells assayed by qPCR
48 WEEKS
Assess cell-associated HIV-1 RNA/DNA ratio in participants with detectable cell-associated HIV-1 DNA prior to ART initiation and while HIV-1 RNA is suppressed on ART
48 WEEKS
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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.

What are the signs of infections?

There are many possible signs of infections. Specific areas of the body are more likely to be infected with a particular organism. The most common sign of an infection is pain.

Anonymous Patient Answer

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

In 2015, the rate of infections among adults was 13 per 1,000 person years; among children and adolescents, it was 5 per 1,000 person years. While infection is the second most common cause of death among all infectious diseases, it is the fourth most common cause of death among infectious disease outbreaks.

Anonymous Patient Answer

What is infections?

Some infections, for example pneumonia, myocarditis, meningitis and sepsis, can be related with many neurological complications. In patients with central nervous system disease, the infections are the most common causes of hospitalizations or deaths.

Anonymous Patient Answer

What are common treatments for infections?

What treatments are used for infections? A complete list is listed below. In some cases, the list was incomplete. As an example, the list of common treatments for infections excludes some anticoagulants, such as warfarin.\n- "Aerobic bacterial (Gram-positive)\n- "Gram-positive bacteriophage (Bacteriophage)\n- "Anaerobic bacterial (Gram-positive) (L. fermentans)\n- "Anaerobic bacterial (L. acidophilus)\n- Anaerobic bacterial (L.

Anonymous Patient Answer

What causes infections?

The types of infections, their severity and probability of developing, are different for infections in adults compared to infants. Different types of infection have their own causes, and are also associated with different risk factors.\n

Anonymous Patient Answer

Can infections be cured?

A few infections, including HIV and syphilis, can be successfully eradicated or overcome with the use of drugs and, in some cases, other health interventions. However, in a globalized world, many other diseases and infections are becoming increasingly problematic because of emerging drug resistance and a limited number of available medications and health resources. These problems can be resolved by eliminating the underlying infection or disease, but the eradication of a persistent viral or other bacterial infection or disease will be much more difficult. Thus, the goals of global public health can be achieved either by treating existing infections or diseases, or by reducing the incidence of new infections by improving public health practices, education, and improved facilities for care, delivery, and diagnosis.

Anonymous Patient Answer

What is the primary cause of infections?

As our study shows, the main cause of upper infectious episodes in a German university hospital is still not completely known. Despite the fact that patient infection prophylaxis is performed routinely since the early 1980s, we could not identify the respective risk groups for specific microorganisms. Patients with chronic illnesses, such as cystic fibrosis, and patients with previous surgeries (e.g., [biliary duct, bone graft]?) are more prone to acquire infections. Results from a recent clinical trial warrant the implementation of an individual patient risk stratification for infections in medical and surgical intensive care units. The prevention of secondary infections in these patients would be of particular interest because they are responsible for a high turnover rate of surgical intensive care units.

Anonymous Patient Answer

Is elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate fda-approved antiretroviral therapy safe for people?

The use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, a once-daily regimen approved by the fda for antiretroviral therapy, in a population with significant comorbidities, was reported to be well tolerated, with no appreciable risk of neuropathies, nephrolithiasis, or hyperlipidemia compared with other antiretroviral regimens that are commonly used in clinical practice.

Anonymous Patient Answer

How does elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate fda-approved antiretroviral therapy work?

The initial results indicate that a "tenofovir-elvitegravir-cobicistat" regimen is associated with good response. However, caution is warranted in its use, as there is still a need to confirm non-nucleoside protease inhibitor resistance profiles.

Anonymous Patient Answer

What is elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate fda-approved antiretroviral therapy?

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide seems an effective regimen for treatment-naive HIV-infected patients in terms of viral suppression and the development of resistance in the absence of ARTs. Furthermore, the most frequent adverse events observed in this analysis were expected.

Anonymous Patient Answer

What are the common side effects of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate fda-approved antiretroviral therapy?

Treatment with FDC-based antiretroviral regimens for the treatment of HIV-1 infection is well tolerated. In clinical trials, the most common side effects of FDC-based therapy were diarrhea, nausea, headache, and abdominal pain. FDC-based treatment may minimize or eliminate the need for antimanic agents and could reduce the use of antihistamines. There have been no reports in the medical literature of serious adverse effects, and the possibility of drug interactions is not expected.

Anonymous Patient Answer

What does elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate fda-approved antiretroviral therapy usually treat?

There is a need for improved treatment options that optimize suppression of HIV replication to prevent opportunistic infections and improve survival in the setting of advanced HIV disease or HIV/ART drug resistance.

Anonymous Patient Answer
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