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