Dolutegravir/Lamivudine for HIV Infections

Phase-Based Estimates
3
Effectiveness
3
Safety
Saint Michael's Medical Center, Newark, NJ
HIV Infections+2 More
Dolutegravir/Lamivudine - Drug
Eligibility
18+
All Sexes
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether switching patients to a different drug may help improve their health.

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Eligible Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Human Immunodeficiency Virus (HIV) Infections

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Dolutegravir/Lamivudine will improve 1 primary outcome and 2 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of 48 weeks.

48 weeks
Virologic Failure
96 weeks
Retrospective Baseline Resistance
Virologic Suprresion

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
dolutegravir/lamivudine

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dolutegravir/Lamivudine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

dolutegravir/lamivudine
Drug
dolutegravir/lamivudine
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 96 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 96 weeks for reporting.

Who is running the study

Principal Investigator
J. S.
Jihad Slim, MD
Saint Michael's Medical Center

Closest Location

Saint Michael's Medical Center - Newark, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmed HIV-1 infection
Age of 18 years or older
On Biktarvy for at >24 weeks with HIV viral load < 50 copies /mL for > 6 months immediately prior to enrollment
Agree to consistently use an effective method of contraception (see Appendix: Highly Effective Methods for Avoiding Pregnancies in Females of Reproductive Potential) for women of child-bearing potential
Willingness to sign the informed consent
If history of virologic failure must be fully suppressed (HIV-1 RNA<50 copies/mL) for at least 12 months before screening visit
No prior HIV genotype or phenotype available

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 causes hiv infections?

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HIV infections result from the sexual contact or exposure from an infected person. HIV infection can increase the rate of some types of arthritis, but not systemic lupus erythematosus.

Unverified Answer

Can hiv infections be cured?

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Though HIV is highly transmissible and life-threatening, early HIV diagnosis and use of HAART can decrease the risk of transmission to a degree that individuals can be cured from infection.

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What are the signs of hiv infections?

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There is no single sign that can reliably diagnose HIV infection. Any other symptom of HIV infection should be evaluated carefully. Symptoms often are similar to those for other opportunistic infections. Symptoms are more likely to be present when a person has other symptoms such as headaches, abdominal pain or fever. Any unexplained fever should be evaluated promptly. HIV infection may cause the symptoms of pneumonia or meningitis. Finally, individuals infected with HIV may suffer from psychiatric illness (though not as frequently as in general population) and thus many mental illnesses may be confused with HIV infection.

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What is hiv infections?

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More than 30% of people living with HIV will have other opportunistic infections, such as malaria, tuberculosis, or pneumonia. To improve overall health, prevention and treatment of HIV must be combined with appropriate management of other, frequently life-threatening, infections.

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

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About 840,000 Americans are thought to be infected with HIV each year, of whom 350,000 (41%) test positive for HIV antibody. Of the 609,000 who are not infected with HIV, around 50,000 will develop AIDS at some time in the next year. Although the number of people with AIDS or HIV disease is increasing, there are still many who are unaware of their infection. This highlights the need to inform those living with HIV of their current and previous HIV status and the fact that HIV testing is crucial in avoiding further transmission. The National Institute for Health and Welfare estimate that some 20,000 new HIV infections result from a single needle-sharing incident.

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What are common treatments for hiv infections?

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While HIV treatment regimens are similar among those living in the United States and those in Europe, the types of antiretroviral medication used in each region could be different. In particular, people in the United States are more likely to be taking zidovudine/lamivudine as first-line therapy for HIV.

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How serious can hiv infections be?

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A high index of suspicion is required when testing for the presence of other HIV-related illnesses, and of course all patients presenting with fever, malaise and anemia require immediate laboratory testing.

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Who should consider clinical trials for hiv infections?

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For patients with hiv-associated symptoms, clinical trials usually are a reasonable approach. Patients on HAART should only consider clinical trials if they have significant symptoms and/or other non-AIDS-related reasons. For patients not on HAART, clinical trials are generally not recommended for their symptoms. Many patients are more likely to have symptoms associated with HIV than other common viral illnesses such as HSV. In addition, many patients who complain of HIV-related symptoms have other serious illnesses such as tuberculosis or HIV-associated malignancies, and clinicians should not only focus on their AIDS symptoms; patients should have their symptoms managed regardless of concurrent HIV status.

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Has dolutegravir/lamivudine proven to be more effective than a placebo?

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In a randomized placebo-controlled study, the combination dolutegravir/lamivudine was non-inferior to placebo in treating HIV-infected adults. No difference was found in the incidence of NNRTI class resistance mutations in HIV-infected adults receiving dolutegravir/lamivudine as compared to placebo.

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How does dolutegravir/lamivudine work?

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DLV/3TC is generally well tolerated, lowers viral load and induces a strong immune response, which may limit the establishment of drug-resistant strains of HIV-1 and help to prevent the disease of developing in individuals taking these drug combinations.

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What is dolutegravir/lamivudine?

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Dolutegravir/lamivudine is an effective antiretroviral regimen in patients with HIV infection and has recently been approved by the FDA"

"Paracalyptra\n\nParacalyptra is a genus of moths belonging to the family Tineidae"

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Is dolutegravir/lamivudine typically used in combination with any other treatments?

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Dolutegravir/lamivudine can produce meaningful antiviral activity in the absence of antiviral medications, although antiviral activity in these settings may not be durable. Combination with other antiviral medications is generally recommended for people with suppressed HIV-1.

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