A Phase 4 interventional study of Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg and Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg in HIV (Human Immunodeficiency Virus) and Sleep, sponsored by University of Witwatersrand, South Africa. Not yet recruiting. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Witwatersrand, South Africa · Phase 4, Interventional, and Treatment
In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.
Background With the successful scale-up of antiretroviral therapy (ART), HIV infection has transitioned from a fatal disease to a chronic, manageable condition. This has led to substantial reductions in AIDS-related mortality globally and marked improvements in life expectancy among people living with HIV (PLWH), including in South Africa where ART coverage and viral suppression rates continue to rise. As a result, HIV care has increasingly shifted toward long-term health optimization, with growing attention to non-communicable diseases (NCDs) such as cardiovascular disease, obesity, and metabolic dysfunction.
Sleep disturbance is increasingly recognized as a potentially important but underappreciated contributor to morbidity in PLWH. Poor sleep is highly prevalent in this population and has been associated with adverse cardiometabolic, neurocognitive, and functional outcomes. Reported prevalence estimates of sleep disturbance in PLWH are as high as 50% or more, significantly exceeding that of the general population. However, most existing data rely on subjective questionnaires such as the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and screening tools for obstructive sleep apnoea (OSA). While these tools are useful for identifying symptoms, they are less sensitive to subtle or early physiological changes in sleep and may not adequately capture sleep as a multidimensional construct.
Contemporary sleep science conceptualises sleep health as a multidimensional construct encompassing satisfaction, alertness, timing, efficiency, duration, and regularity, rather than simply the absence of sleep disorders. Instruments such as RU-SATED have been developed to capture these domains; however, few studies have applied multidimensional sleep health frameworks in PLWH, and even fewer have evaluated how sleep health differs across antiretroviral regimens.
Objective sleep assessment using overnight polysomnography (PSG) provides a gold-standard method for characterising sleep architecture and physiology. PSG enables measurement of sleep stages (N1, N2, N3, and REM sleep), sleep continuity, respiratory events, oxygen desaturation, arousals, and other physiological parameters. Sleep architecture reflects the distribution of time spent across sleep stages, each of which plays distinct physiological roles. In healthy adults, sleep typically consists of approximately 50% N2, 20% N3 (slow-wave sleep), 25% REM sleep, and 5% N1 sleep, cycling throughout the night. N3 sleep is particularly important for physical restoration and metabolic regulation, while REM sleep is involved in emotional regulation and cognitive processing. Disruption of these stages, as well as sleep fragmentation and altered sleep continuity, has been associated with adverse health outcomes including cardiovascular disease, neurocognitive decline, and metabolic dysfunction.
Although PSG studies in PLWH are limited, existing evidence suggests consistent abnormalities in sleep architecture and continuity. Studies have reported reduced sleep efficiency, increased wake after sleep onset, altered distribution of sleep stages, reduced slow-wave sleep, and disrupted REM patterns in PLWH compared with HIV-negative controls. These abnormalities appear to persist even in virologically suppressed individuals on ART. Some evidence suggests that PLWH may exhibit increased vulnerability to sleep disruption in the presence of comorbid conditions such as obstructive sleep apnoea, with more pronounced effects on sleep architecture than in HIV-negative populations. Importantly, most PSG studies in PLWH have been conducted in predominantly male cohorts, limiting generalisability to women.
There is also significant interest in the potential role of antiretroviral agents in influencing sleep physiology. Efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), is well known to cause neuropsychiatric side effects, including insomnia and alterations in REM and slow-wave sleep. In contrast, dolutegravir (DTG), an integrase strand transfer inhibitor (INSTI), is widely used due to its efficacy and tolerability but has been associated with neuropsychiatric symptoms and weight gain in some studies. While weight gain associated with DTG is recognised, the potential role of sleep disturbance as a mechanistic pathway contributing to metabolic outcomes has not been well explored. Given the bidirectional relationship between sleep and weight regulation, it is plausible that changes in sleep architecture may contribute to or exacerbate metabolic risk in individuals receiving DTG-based regimens.
Doravirine (DOR), a newer NNRTI, appears to have a more favourable neuropsychiatric and metabolic profile compared with older agents. Clinical trials have reported lower rates of sleep-related adverse events in participants receiving DOR compared with EFV, and improvements in neuropsychiatric symptoms following switches to DOR-based regimens. However, no studies to date have directly assessed objective sleep architecture using polysomnography in individuals receiving DOR or compared its effects to DTG.
A critical gap therefore exists in understanding whether specific ART regimens differentially influence sleep health and sleep architecture over time, and whether these effects are clinically meaningful. In particular, it remains unclear whether sleep disturbance in PLWH is primarily driven by HIV infection itself, by antiretroviral agents, or by an interaction between the two.
Study Rationale This study is designed to address key gaps in understanding the relationship between ART, sleep health, and metabolic outcomes in PLWH. Specifically, it aims to determine whether DTG-based and DOR-based regimens differentially affect subjective sleep health and objective sleep architecture over time.
Given the increasing global burden of obesity and cardiometabolic disease in PLWH, understanding potential mechanistic links between ART, sleep, and metabolic outcomes is essential. Emerging evidence suggests that sleep quality, rather than sleep duration alone, may be more strongly associated with body mass index and long-term metabolic health. Therefore, identifying whether ART regimens differentially affect sleep quality may have important implications for long-term treatment selection and risk reduction.
Study Design This is a prospective, randomized, comparative pilot study evaluating sleep outcomes in adults living with HIV continuing or switching to either a dolutegravir-based ART regimen or a doravirine-based ART regimen, respectively.
Participants will be assigned to one of two treatment groups:
DTG-based regimen (TDF/3TC/DTG; standard of care) DOR-based regimen (TDF/3TC/DOR)
The study will evaluate both subjective and objective sleep outcomes over time.
Significance This study addresses a major gap in HIV research by integrating multidimensional subjective sleep assessment with gold-standard objective sleep physiology measurements in a randomized comparative ART context in South Africa. It will provide novel evidence on whether DTG- and DOR-based regimens differentially affect sleep health, and whether these effects are clinically meaningful and associated with metabolic risk.
Findings will inform the design of a future fully powered clinical trial, including refinement of endpoints and sample size calculations, and may contribute to more individualized ART selection strategies that consider long-term sleep and metabolic health in PLWH.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 40 is below the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Witwatersrand, South Africa is the lead sponsor of 47 studies on the registry; 4 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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Each participant must meet all the following criteria to be enrolled in this study:
Exclusion Criteria:
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Participants meeting any of the following criteria will be excluded from the study:
Evidence of a sleep disorder at screening, based on history, the site-specific Sleep Disorders Screening Tool (SDST) and/or polysomnography, including but not limited to:
Use of medications known to significantly alter sleep, including (but not limited to):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and dolutegravir 50 mg (TDF/3TC/DTG; TLD) is the recommended first-line antiretroviral regimen for adults weighing ≥30 kg, according to the South African National ART Guidelines (2026). Participants randomised to continue TLD will serve as the control arm.
Drug: Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg
DELSTRIGO (TDF/3TC/DOR) is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor \[NNRTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV infection in adults and adolescent individuals weighing at least 35 kg. One tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate.
Drug: Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg
Drug page: Tenofovir
DELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor \[NNRTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV infection in adults and adolescent individuals weighing at least 35 kg. One tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate. Participants will be required to take one tablet PO daily for the duration of the study.
Also known as: Delstrigo
Drug page: Tenofovir
Tenofovir disoproxil fumarate 300mg /lamivudine 300mg /dolutegravir 50mg (fixed dose combination tablet) one tab taken orally daily for the duration of the study.
Also known as: TLD
Change in RU-SATED total score from baseline to week 12
RU-SATED Questionnaire (Total Score: 0-24) Sleep health will be assessed using the RU-SATED sleep health questionnaire, a validated multidimensional measure comprising six domains of sleep health: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Each domain is scored on a scale of 0-4, with higher scores indicating better sleep health. The total score ranges from 0 to 24, with higher scores reflecting overall better sleep health. The six items are as follows: Regularity: I go to sleep and wake up at about the same time every day. Duration: I sleep 7-9 hours per night. Timing: The midpoint of my sleep period is between 2:00 a.m. and 4:00 a.m. Efficiency: I am awake for less than 30 minutes between the time I go to bed and the time I get out of bed. Alertness: I stay awake all day without dozing. Satisfaction: I am satisfied with my sleep.
Time frame: Baseline and Week 12
Between-Arm Difference in RU-SATED Total Sleep Health Score at Week 12
The RU-SATED questionnaire will be used to assess multidimensional sleep health across six domains: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Each domain is scored from 0 to 4, with higher scores indicating better sleep health. The total RU-SATED score ranges from 0 to 24, with higher scores indicating better overall sleep health. Between-arm differences will compare mean RU-SATED total scores between participants switching from DTG-based ART to DOR-based ART and those continuing DTG-based ART at Week 12.
Time frame: Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Sleep Stage Distribution (N1, N2, N3, REM)
Sleep architecture will be assessed using overnight polysomnography (PSG). Sleep stage distribution (N1, N2, N3, and REM) will be expressed as percentage of total sleep time.
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Sleep Latency
Sleep latency will be measured using overnight PSG and defined as the time from lights-off to sleep onset
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived REM Latency
REM latency will be measured using overnight PSG and defined as the time from sleep onset to the first epoch of REM sleep
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Total Sleep Time
Total sleep time (TST) will be measured using PSG and defined as the total duration of sleep obtained during the recording period
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Sleep Efficiency
Sleep efficiency will be measured using PSG and calculated as the percentage of time spent asleep while in bed
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Wake After Sleep Onset
Wake after sleep onset (WASO) will be measured using PSG and defined as the total time spent awake after initial sleep onset
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Apnea-Hypopnea Index
The apnea-hypopnea index (AHI) will be measured using PSG and defined as the number of apneas and hypopneas per hour of sleep
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in Polysomnography-Derived Oxygen Desaturation Events
Oxygen desaturation events will be measured using PSG and defined as episodes of reduced blood oxygen saturation during sleep below clinically defined thresholds
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in PROMIS Sleep Disturbance Short Form 8a T-score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) Short Form 8a and Sleep-Related Impairment (SRI) Short Form 8a will be used to assess subjective sleep health and daytime impairment. Each instrument produces a T-score with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater sleep disturbance or greater sleep-related impairment, respectively. The PROMIS SD SF 8a assesses perceptions of sleep quality, depth, and restfulness, while the PROMIS SRI SF 8a assesses perceived daytime functioning and alertness related to sleep.
Time frame: Baseline and Week 12
Change from Baseline to Week 12 in PROMIS Sleep Related Impairment Short Form 8a T-score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) Short Form 8a and Sleep-Related Impairment (SRI) Short Form 8a will be used to assess subjective sleep health and daytime impairment. Each instrument produces a T-score with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater sleep disturbance or greater sleep-related impairment, respectively. The PROMIS SD SF 8a assesses perceptions of sleep quality, depth, and restfulness, while the PROMIS SRI SF 8a assesses perceived daytime functioning and alertness related to sleep.
Time frame: Baseline and Week 12
Participant Recruitment Rate
Recruitment rate will be defined as the proportion of eligible participants who provide informed consent and are enrolled into the study out of all individuals screened for eligibility.
Time frame: From initiation of recruitment until enrollment of the final participant, assessed over approximately 12 months
Participant Retention Rate Through Week 12
Retention rate will be defined as the proportion of enrolled participants who complete the study follow-up visit at Week 12.
Time frame: Baseline and Week 12
Polysomnography Completion and Data Quality Success Rate
Polysomnography (PSG) success rate will be defined as the proportion of participants with technically adequate overnight PSG recordings that are suitable for analysis, including sufficient signal quality and complete sleep staging data.
Time frame: Baseline and Week 12
Actigraphy Success Rate
Actigraphy success rate will be defined as the proportion of consenting participants with valid actigraphy recordings meeting predefined wear-time criteria (% complete ≥ 2 valid nights) sufficient for sleep parameter analysis.
Time frame: Baseline and Week 12
Internal consistency of the RU-SATED questionnaire measured by Cronbach's alpha
Preliminary psychometric evaluation of the RU-SATED questionnaire will be conducted, including internal consistency reliability (e.g., Cronbach's alpha).
Time frame: Baseline and Week 12
Correlation between RU-SATED score and PROMIS Sleep Disturbance SF 8a
Convergent validity assessed via Spearman correlations between RU-SATED and PROMIS SD SF 8a
Time frame: Baseline and Week 12
Sleep Duration Measured by Actigraphy at Baseline and Week 12
Actigraphy will be used to characterise habitual sleep patterns in the study cohort, including estimates of total sleep time.
Time frame: Baseline and Week 12
Sleep Efficiency Measured by Actigraphy at Baseline and Week 12
Actigraphy will be used to characterise habitual sleep patterns in the study cohort, including sleep efficiency.
Time frame: Baseline and Week 12
Number of Nocturnal Awakenings Measured by Actigraphy at Baseline and Week 12
Actigraphy will be used to characterise habitual sleep patterns in the study cohort, including the number of nocturnal awakenings.
Time frame: Baseline and Week 12
Changes in Inflammatory Biomarkers from Baseline to Week 12
Changes in inflammatory biomarkers, including high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6), will be assessed from baseline to Week 12.
Time frame: Baseline and Week 12
Sleep Quality Measured using a Numeric Rating Scale at Baseline and Week 12
A numeric rating scale for sleep quality will be evaluated for feasibility and differences between baseline and Week 12 will be assessed. Participants will be asked to rate their overall sleep quality in the past seven days using a 0-10 numeric rating scale.
Time frame: Baseline and Week 12
Daytime Sleepiness Measured using the Pictorial Sleepiness Scale at Baseline and Week 12
A pictorial sleepiness scale will be evaluated for feasibility and values at baseline and Week 12 will be assessed. The pictorial sleepiness scale uses a series of cartoon faces to represent different levels of sleepiness and has been validated for use in South Africa
Time frame: Baseline and Week 12
Change in Appetite Following Switch from Dolutegravir-Based to Doravirine-Based Antiretroviral Therapy
Changes in self-reported appetite will be assessed following the switch from dolutegravir-based antiretroviral therapy to doravirine-based antiretroviral therapy using a brief, site-derived questionnaire developed by the study team. The instrument consists of seven 7-day recall items designed to capture appetite and eating-related constructs relevant to a South African context, including food security (e.g., food availability and forced reduction of portion sizes), appetite intensity (unexpected hunger), eating control (ability to stop eating when full), and meal satisfaction. Each item is assessed using a 5-point Likert-type scale. Responses across the appetite and eating behaviour domains are summed to generate a total score out of 20, with higher scores indicating greater appetite and eating-related functioning. The two food security-related items will be analysed separately to reflect structural access to food rather than appetite behaviour.
Time frame: Baseline and Week 12
Characterisation of Sleep Behaviours and Environmental Sleep Disruptors in a South African Context
Sleep behaviours, sleep patterns, and environmental sleep disruptors will be assessed using a General Sleep Questionnaire administered at screening. The questionnaire is designed to capture usual sleep habits and participant perceptions of sleep. This exploratory assessment represents an initial step toward characterising sleep in a South African population and informing the future development of contextually relevant sleep measurement tools for use in African settings.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Yes — The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Informed consent form
Time frame: Immediately following publication
Access criteria: Anyone who wishes to access the data
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tenofovir
Acquired Immunodeficiency Syndrome →
University of Witwatersrand, South Africa