A Phase 2 interventional study of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy in HIV-1 Infection, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Completed at 30 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Phase 2, Interventional, and Treatment
The study was done to:
This was a Phase II, prospective, open-label two-step study to measure the effects of early ART on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants were enrolled if they fulfilled the inclusion criteria for acute HIV-1 infection (AHI) diagnosis within 7 days prior to entry and had an enrollment visit with the immediate initiation of ART. Plasma and serum samples for Fiebig staging were collected at the time of ART initiation.
Participants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.
The Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).
The primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.
Group 1: Fiebig I/II (non-reactive HIV-1 antibody)
Group 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)
Group 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)
Although participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.
The study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the lead sponsor of 70 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Appropriate documentation from medical records of diagnosis of acute -1 infection (AHI) within 7 days prior to enrollment, that includes one of the following:
Note A: HIV-1 RNA result must be reported from an FDA-approved or CE-marked assay.
Note B: Since characterization of Fiebig stage using samples at the time of ART initiation was performed with results known within 12 weeks based on standardized, centralized testing, an estimated Fiebig group at enrollment based on inclusion criteria as shown in the table above will provide additional real-time monitoring for accruals into each study group.
Female candidates are considered to be of reproductive potential if any of the following conditions apply:
Acceptable contraceptive methods include:
Female candidates who are not of reproductive potential or whose male partner(s) has documented azoospermia are not required to use contraceptives. Any statement of self-reported sterility or that of her partner must be entered in the source documents.
NOTE: Acceptable documentation of lack of reproductive potential is oral or written documentation from the individual.
Female candidates who are prescribed a non-study-provided ARV regimen should discuss the safety of that regimen during conception and pregnancy with the prescribing physician. Such individuals should follow medical guidance regarding any potential need for contraception while using the non-study-provided ARV regimen.
Note: Pregnant and breastfeeding women may enroll in the study provided that they meet the eligibility requirements and have access to non-study-provided ARV regimens.
Exclusion Criteria:
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.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask 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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).
Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Also known as: Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya, Single-tablet regimen BIC/FTC/TAF or Biktarvy
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Time frame: At week 48
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
Time frame: At week 48
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
Time frame: At 48 weeks
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
Time frame: At week 0
Participants were enrolled from January 2017 to December 2019 at 30 sites in Brazil, Malawi, Peru, Thailand, United States, and Zimbabwe.
| Milestone | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative |
|---|---|---|---|---|---|
| Started | 49 | 79 | 60 | 4 | 3 |
| Completed week 48 | 41 | 68 | 50 | 0 | 0 |
| Completed | 37 | 67 | 49 | 4 | 0 |
| Not completed | 12 | 12 | 11 | 0 | 3 |
| Withdrew: Not eligible | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Lost to follow-up | 1 | 3 | 3 | 0 | 0 |
| Withdrew: Did not return to clinic | 2 | 3 | 4 | 0 | 0 |
| Withdrew: Moved | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by participant | 1 | 2 | 1 | 0 | 0 |
| Withdrew: Had to interrupt antiretroviral (arv) | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Incarceration | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Non-adherence to study drug | 2 | 0 | 1 | 0 | 0 |
| Withdrew: Non-adherence to study requirements | 3 | 1 | 0 | 0 | 0 |
| Withdrew: Virologic failure | 2 | 1 | 1 | 0 | 0 |
| Milestone | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative |
|---|---|---|---|---|---|
| Started | 26 | 42 | 23 | 0 | 0 |
| Completed | 22 | 37 | 19 | 0 | 0 |
| Not completed | 4 | 5 | 4 | 0 | 0 |
| Withdrew: Lost to follow-up | 3 | 3 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Unexpected closure of site | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Incarceration | 0 | 0 | 1 | 0 | 0 |
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
| Proportion of participants | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V |
|---|---|---|---|
| Joint Assay (Integrase + Gag) | 0.00 (0.00 to 0.09) | 0.00 (0.00 to 0.06) | 0.00 (0.00 to 0.07) |
| Integrase Assay | 0.10 (0.03 to 0.24) | 0.06 (0.02 to 0.15) | 0.10 (0.03 to 0.22) |
| Gag Assay | 0.03 (0.00 to 0.13) | 0.02 (0.00 to 0.08) | 0.00 (0.00 to 0.07) |
Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
| Percentage of CD4+ T-cells | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V |
|---|---|---|---|
| CD4+ T-cell Response to Env | 0.00 (0.00 to 0.24) | 0.00 (0.00 to 0.09) | 0.08 (0.00 to 0.17) |
| CD4+ T-cell Response to Gag | 0.06 (0.00 to 0.23) | 0.19 (0.03 to 0.31) | 0.14 (0.05 to 0.27) |
| CD4+ T-cell Response to Nef | 0.04 (0.00 to 0.15) | 0.10 (0.00 to 0.26) | 0.10 (0.00 to 0.23) |
| CD4+ T-cell Response to Pol | 0.00 (0.00 to 0.03) | 0.04 (0.00 to 0.13) | 0.04 (0.00 to 0.19) |
Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
| Percentage of CD8+ T-cells | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V |
|---|---|---|---|
| CD8+ T-cell Response to Env | 0.00 (0.00 to 0.03) | 0.00 (0.00 to 0.08) | 0.00 (0.00 to 0.36) |
| CD8+ T-cell Response to Gag | 0.15 (0.00 to 0.36) | 0.33 (0.06 to 0.67) | 0.28 (0.00 to 0.61) |
| CD8+ T-cell Response to Nef | 0.03 (0.00 to 0.32) | 0.15 (0.00 to 0.44) | 0.33 (0.04 to 0.68) |
| CD8+ T-cell Response to Pol | 0.00 (0.00 to 0.08) | 0.05 (0.00 to 0.23) | 0.08 (0.00 to 0.26) |
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR \[qPCR\]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
| Proportion of participants | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V |
|---|---|---|---|
| Joint Assay (Integrase + Gag) | 0.00 (0.00 to 0.07) | 0.01 (0.00 to 0.07) | 0.00 (0.00 to 0.06) |
| Integrase Assay | 0.04 (0.01 to 0.14) | 0.03 (0.00 to 0.09) | 0.07 (0.02 to 0.16) |
| Gag Assay | 0.00 (0.00 to 0.07) | 0.01 (0.00 to 0.07) | 0.00 (0.00 to 0.06) |
Collected over Step 1: From study entry to Step 1 Week 72, Step 2 entry, or premature study discontinuation on Step 1. Step 2: From step 2 entry to Step 2 Week 144 or premature study discontinuation on Step 2.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Step 1 Arm 1: Fiebig I/II | 0/49 (0%) | 5/49 (10.2%) | 48/49 (98%) |
| Step 1 Arm 2: Fiebig III/IV | 0/79 (0%) | 7/79 (8.9%) | 67/79 (84.8%) |
| Step 1 Arm 3: Fiebig V | 0/60 (0%) | 4/60 (6.7%) | 50/60 (83.3%) |
| Step 1 Fiebig VI | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Step1 HIV Negative | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Step 2 Arm 1: Fiebig I/II | 1/26 (3.8%) | 6/26 (23.1%) | 18/26 (69.2%) |
| Step 2 Arm 2: Fiebig III/IV | 0/42 (0%) | 4/42 (9.5%) | 30/42 (71.4%) |
| Step 2 Arm 3: Fiebig V | 0/23 (0%) | 3/23 (13%) | 15/23 (65.2%) |
| Event | Step 1 Arm 1: Fiebig I/II | Step 1 Arm 2: Fiebig III/IV | Step 1 Arm 3: Fiebig V | Step 1 Fiebig VI | Step1 HIV Negative | Step 2 Arm 1: Fiebig I/II | Step 2 Arm 2: Fiebig III/IV | Step 2 Arm 3: Fiebig V |
|---|---|---|---|---|---|---|---|---|
| Fascial infectionInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
| Peritonsillar abscessInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
| Suicidal ideationPsychiatric disorders | 1/49 | 1/79 | 1/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
| Suicide attemptPsychiatric disorders | 2/49 | 1/79 | 1/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
| Myocardial infarctionCardiac disorders | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| AppendicitisInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| COVID-19Infections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| Lymphadenitis bacterialInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| MonkeypoxInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| Pneumococcal sepsisInfections and infestations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 1/26 | 0/42 | 0/23 |
| Event | Step 1 Arm 1: Fiebig I/II | Step 1 Arm 2: Fiebig III/IV | Step 1 Arm 3: Fiebig V | Step 1 Fiebig VI | Step1 HIV Negative | Step 2 Arm 1: Fiebig I/II | Step 2 Arm 2: Fiebig III/IV | Step 2 Arm 3: Fiebig V |
|---|---|---|---|---|---|---|---|---|
| Creatinine renal clearance decreasedInvestigations | 37/49 | 61/79 | 45/60 | 4/4 | 2/3 | 0/26 | 9/42 | 2/23 |
| Blood creatinine increasedInvestigations | 16/49 | 23/79 | 16/60 | 0/4 | 0/3 | 2/26 | 4/42 | 4/23 |
| HypertensionVascular disorders | 2/49 | 2/79 | 1/60 | 1/4 | 0/3 | 1/26 | 1/42 | 0/23 |
| Anal chlamydia infectionInfections and infestations | 4/49 | 0/79 | 2/60 | 0/4 | 0/3 | 5/26 | 2/42 | 0/23 |
| Proctitis chlamydialInfections and infestations | 1/49 | 1/79 | 1/60 | 0/4 | 0/3 | 1/26 | 4/42 | 4/23 |
| Latent syphilisInfections and infestations | 4/49 | 2/79 | 1/60 | 0/4 | 0/3 | 4/26 | 4/42 | 0/23 |
| Alanine aminotransferase increasedInvestigations | 6/49 | 5/79 | 2/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
| Blood cholesterol increasedInvestigations | 0/49 | 1/79 | 0/60 | 0/4 | 0/3 | 3/26 | 1/42 | 0/23 |
| Low density lipoprotein increasedInvestigations | 0/49 | 0/79 | 0/60 | 0/4 | 0/3 | 3/26 | 0/42 | 0/23 |
| Aspartate aminotransferase increasedInvestigations | 5/49 | 5/79 | 4/60 | 0/4 | 0/3 | 0/26 | 0/42 | 1/23 |
All participants with available baseline measurements.
| Age, Continuous(years) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| Median | 26 (22 to 35) | 30 (24 to 40) | 26 (23 to 38) | 36 (22 to 48) | 25 (19 to 39) | 27 (23 to 39) |
| Age, Customized(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| 18-29 years | 31 | 39 | 36 | 2 | 2 | 110 |
| 30-39 years | 12 | 18 | 12 | 0 | 1 | 43 |
| 40-49 years | 4 | 12 | 6 | 2 | 0 | 24 |
| 50+ years | 2 | 10 | 6 | 0 | 0 | 18 |
| Sex/Gender, Customized(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| Cisgender | 47 | 73 | 60 | 4 | 2 | 186 |
| Transgender Spectrum | 1 | 5 | 0 | 0 | 0 | 6 |
| Not Reported | 1 | 1 | 0 | 0 | 1 | 3 |
| Sex: Female, Male(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| Female | 4 | 12 | 11 | 2 | 1 | 30 |
| Male | 45 | 67 | 49 | 2 | 2 | 165 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 17 | 30 | 18 | 1 | 2 | 68 |
| Not Hispanic or Latino | 32 | 48 | 42 | 3 | 1 | 126 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 12 | 1 | 1 | 0 | 0 | 14 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 19 | 35 | 39 | 3 | 1 | 97 |
| White | 14 | 36 | 16 | 0 | 0 | 66 |
| More than one race | 0 | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 4 | 7 | 4 | 0 | 2 | 17 |
| Region of Enrollment(Participants) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| United States | 25 | 65 | 42 | 1 | 0 | 133 |
| Malawi | 4 | 3 | 3 | 0 | 1 | 11 |
| Brazil | 6 | 10 | 8 | 1 | 0 | 25 |
| Zimbabwe | 0 | 0 | 6 | 2 | 0 | 8 |
| Thailand | 12 | 1 | 0 | 0 | 0 | 13 |
| Peru | 2 | 0 | 1 | 0 | 2 | 5 |
| BMI(kg/m^2) | Arm 1: Fiebig I/II | Arm 2: Fiebig III/IV | Arm 3: Fiebig V | Fiebig VI | HIV-negative | Total |
|---|---|---|---|---|---|---|
| Median | 22.5 (20.3 to 25.6) | 25.9 (21.4 to 28.8) | 23.8 (21.4 to 28.2) | 22.7 (17.7 to 28.4) | 23.2 (19.4 to 26.1) | 24.0 (21.2 to 28.0) |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally (ACTG) by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.
Ran from Jan 2017 to primary completion in Dec 2020, 46 months.
Results were first posted in Jan 2022, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections