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| Name | Class |
|---|---|
| University of KwaZulu | OTHER |
| Lighthouse Trust | OTHER |
| Centre for Infectious Disease Research in Zambia | OTHER |
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This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (InSTI), is widely used in high-income countries and is recommended by the World Health Organization (WHO) as an alternative first-line ART regimen. In countries where viral load monitoring is not routinely available many patients on first-line ART will be switched to a DTG-based regimen despite the detectable viral load, which could increase the risk of selection of resistance to DTG as the majority of patients with virologic failure on first-line EFV-based ART have NRTI mutations. The investigators hypothesize that the proportion of patients experiencing virologic failure 48 and 96 weeks after switching to a DTG-based regimen will be higher in patients who switched with virologic failure (VL>400 copies/mL) compared to patients who switched with suppressed viral replication (VL<400 copies/mL). This is a prospective observational cohort study of 2820 patients on first-line ART switching to a DTG-based first-line regimen, according to the standard of care. The study is conducted in Malawi and Zambia, in ART programs that participate in the IeDEA collaboration. At the time of switching to DTG, a baseline study assessment will be done, and a blood sample will be taken. Sequencing will be done on blood samples of patients with a viral load above 400 copies/mL to identify mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lighthouse Trust in Lilongwe | |||
| CIDRZ in Lusaka |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with VF at 48 weeks between patients with and without VF at baseline. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with VF at 96 weeks between patients with and without VF at baseline. | 96 weeks | |
| The incidence of TLD drug resistances at 48 and 96 weeks in patients with and without VF at switch. | 48 and 96 weeks |
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Inclusion Criteria:
Patients
Exclusion Criteria:
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People living with HIV.
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Egger, Prof. | University of Berne | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lighthouse Trust | Lilongwe | Malawi | ||||
| CIDRZ |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38847281 | Derived | Skrivankova VW, Huwa J, Muula G, Chiwaya GD, Banda E, Buleya S, Chihota B, Chintedza J, Bolton C, Tweya H, Kalua T, Hossmann S, Kouyos R, Wandeler G, Egger M, Lessells RJ. Virologic Failure and Drug Resistance After Programmatic Switching to Dolutegravir-based First-line Antiretroviral Therapy in Malawi and Zambia. Clin Infect Dis. 2025 Feb 5;80(1):120-128. doi: 10.1093/cid/ciae261. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| The proportion of HIV-infected patients with VF at baseline. | Baseline |
| The proportion of patients with VF at 48 weeks and 96 weeks in patients with VF at baseline who have at least one or no fully active NRTI on resistance testing. | 48 and 96 weeks |
| Prevalence of neuropsychiatric symptoms at baseline, 48 weeks and 96 weeks. | 48 and 96 weeks |
| Prevalence of insomnia at baseline, 48 weeks and 96 weeks. | 48 and 96 weeks |
| Weight change from baseline to 48 and 96 weeks. | 48 and 96 weeks |
| Levels of adherence at baseline and after 48 and 96 weeks. | 48 and 96 weeks |
| The number of clinical visits whilst on a DTG-based regimen up to 48 and 96 weeks. | 48 and 96 weeks |
| The number of clinical visits up to baseline, 48 and 96 weeks. | 48 and 96 weeks |
| Lusaka |
| Zambia |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |