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Can a single HIV pill tame the epidemic in africa?

NCT ID NCT04066036

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study follows about 1,000 adults in South Africa and Uganda who are switching to a common HIV treatment called TLD, which combines three drugs into one pill. The goal is to see how effective TLD is in everyday conditions, not just in controlled trials. If the treatment stops working for some people, the researchers will look into possible reasons, such as drug resistance or challenges with taking the medication regularly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A three-drug HIV treatment regimen containing lamivudine, tenofovir, and dolutegravir (known as TLD)
What this could lead to
If successful, this could reveal how well TLD works in real-world African settings and help improve HIV care strategies across the region.
What could go wrong
As an observational study, it cannot prove cause and effect. Results may be affected by differences in patient adherence or clinic practices, and the findings might not apply to other regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

999 people

The number who actually took part.

Started

May 2019

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll a total of 1,000 individuals from Uganda and South Africa, who are currently enrolled in care at one of the study clinics who have been taking NNRTI-based ART for a minimum of six months, and who are switching to TLD. 500 participants will be recruited from Uganda, and 500 will be recruited from South Africa.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * HIV-positive and in care at one of the study clinics * Current use of NNRTI-based, first-line ART for a minimum of 6 months * Prescribed change to TLD by clinic staff * Residing within 100 kilometers of the treatment clinic without plans to change permanent residence in the next 48 weeks * Consents to participation Exclusion Criteria: There are no specific exclusion criteria. Both men and women will be theoretically eligible. We note that decision to use TLD in patients at the recruitment clinic will be made by clinic staff, and referral for study procedures will not be made until after this decision is made. We also note that, as of the time of this protocol draft, TLD use might be limited to men, women of non-child bearing ages, and women confirmed to be on contraception. This study will follow both national guidelines and clinician discretion about use of TLD in the clinic population.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

Contacts and locations

Locations

  • Africa Health Research Institute

    Somkele, KwaZulu-Natal, South Africa

  • Mbarara University of Science and Technology

    Mbarara, Uganda

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