Trial reportRetrovirology2018
Lipid levels, insulin resistance and cardiovascular risk over 96 weeks of antiretroviral therapy: a randomised controlled trial comparing low-dose stavudine and tenofovir.
Trial report in Retrovirology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02670772 (A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine), which is not on this map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Efavirenz in Antiretroviral-Naive Patients Infected With HIV-1
Who cites it
12 citing papers in PubMed, 15 citations in OpenAlex.
- Perceptions of body size and non-communicable disease risk among people with HIV in Nairobi, Kenya: an explanatory mixed-methods study.BMJ global health · 2025Article
- No Genetic Causal Relationship Between HIV Infection and Insulin Resistance, Diabetes: A Bidirectional Mendelian Randomization Analysis.Journal of multidisciplinary healthcare · 2025Article
- Spectrum and Correlates of Dyslipidemia in People Living with HIV on Dolutegravir-Based Regimen Attending Kabutare Hospital, Southern Rwanda: A Cross-Sectional Study.HIV/AIDS (Auckland, N.Z.) · 2025Article
- Fasting plasma glucose trends in the elderly living with HIV/AIDS on combination antiretroviral therapy regimens.BMJ open · 2024Article
- Mapping the landscape of research on insulin resistance: a visualization analysis of randomized clinical trials.Journal of health, population, and nutrition · 2024Article
- Amino acid metabolism dysregulation associated with inflammation and insulin resistance in HIV-infected individuals with metabolic disorders.Amino acids · 2023Article
- Drug-induced mitochondrial toxicity: Risks of developing glucose handling impairments.Frontiers in endocrinology · 2023Review
- Antiretroviral Therapy-Induced Dysregulation of Gene Expression and Lipid Metabolism in HIV+ Patients: Beneficial Role of Antioxidant Phytochemicals.International journal of molecular sciences · 2022Review
- Cardiovascular disease (CVD) risk assessment of HIV medication regimens using hematopoietic CD34+ progenitor cells.Stem cell research & therapy · 2022Observational
- Contributory role of ART in the development of non-AIDS comorbidities in asymptomatic PLWHA.Journal of applied biomedicine · 2021Article
- Article
- Is CD4 + T-cell recovery - Associated with hypertension during initial antiretroviral therapy in human immunodeficiency virus patients?Journal of clinical hypertension (Greenwich, Conn.) · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD). We investigated these changes in the first 96 weeks of treatment with low-dose stavudine or tenofovir regimens.
methodsThis is a secondary analysis of a double blind, randomised controlled trial performed in South-Africa, Uganda and India comparing low-dose stavudine (20 mg twice daily) with tenofovir in combination with efavirenz and lamivudine in antiretroviral-naïve adults (n = 1067) (Clinicaltrials.gov, NCT02670772). Over 96 weeks, data were collected on fasting lipids, glucose and insulin. Insulin resistance was assessed with the HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS). A generalized linear mixed model was used to estimate trends over time.
resultsParticipants were on average 35.3 years old, 57.6% female and 91.8% Black African. All lipid levels increased following treatment initiation, with the sharpest increase in the first 24 weeks of treatment. The increase in all lipid subcomponents over 96 weeks was higher among those in the stavudine than the tenofovir group. Insulin resistance increased steadily with no difference detected between study groups. FRS rose from 1.90% (1.84-1.98%) at baseline to 2.06 (1.98-2.15%) at week 96 for the total group, with no difference between treatment arms (p = 0.144). Lipid changes were more marked in Indian than African participants.
conclusionLipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir. Insulin resistance increased, with no difference between regimens. CVD risk increased over time and tended to increase more in the group on stavudine. The low CVD risk across both arms argues against routine lipid and glucose monitoring in the absence of other CVD risk factors. In high risk patients, monitoring may only be appropriate at least a year after treatment initiation.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.