A Phase 3 interventional study of Rilpivirine and Efavirenz in Human Immunodeficiency Virus-type 1 Infection, sponsored by Janssen-Cilag International NV. Completed at 18 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Janssen-Cilag International NV · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).
This is a 48-week, multicenter (study conducted at multiple sites), multinational (conducted at different countries), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to assess whether tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) shows noninferior response rates of human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) suppression less than 400 copies per mL, compared with TDF/FTC/efavirenz (TDF/FTC/EFV). The study consists of 3 phases including, the screening phase (of 6 weeks), treatment phase (of 48 weeks), and follow up phase (of 30 to 35 days after the last dose of study medication). During the 48 weeks treatment phase, patients currently with HIV-1 RNA suppression less than 50 copies per mL on their first-line antiretroviral regimen, will be randomized in a 1:1 ratio, in 2 groups, ie, Group 1 (treatment group) and Group 2 (control group). Both these groups will receive a fixed dose combination (FDC) regimen (ie, FDC tablet: one tablet per day) of either TDF/FTC/RPV in Group 1 or TDF/FTC/EFV in Group 2. Patients will return for study visits at Week 4, 12, 24, 36, and 48 during the treatment period, and then every 24 weeks thereafter during the extended treatment period until the last patient has his or her Week 48 (or treatment discontinuation) visit. Safety evaluations for adverse events, clinical laboratory (central and local) tests, electrocardiogram, vital signs, and physical examination will be performed throughout the study. The treatment duration for each patient will be expected to be between 48 and 108 weeks.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 426 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Janssen-Cilag International NV is the lead sponsor of 66 studies on the registry; none are open to participants now.
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Documented human immunodeficiency virus-type 1 (HIV-1) infection Patients who have been receiving first line highly active antiretroviral therapy (HAART) for at least 1 year before the screening visit Patients who have been taking the same ARV combination for at least 8 weeks before the screening visit and are expected to continue on this regimen throughout the screening period.
Patients who prefer to change the current HAART regimen for reasons of simplification and/or toxicity of nucleoside/nucleotide reverse transcriptase inhibitor (N[t]RTI) Plasma HIV-1 RNA less than 50 copies per mL and CD4+ cell count higher than 200 per mm3 at the screening visit Agrees to protocol-defined use of effective contraception
Exclusion Criteria:
History of virologic failure (2 consecutive plasma HIV-1 ribonucleic acid (RNA) more than or equal to 400 copies per mL) while on previous or current ART History of immunologic failure (2 consecutive CD4+ cell counts during HAART treatment falling below the pre-HAART level) History of any primary N[t]RTI or NNRTI mutations Has a previously documented HIV-2 infection Significantly decreased hepatic function or hepatic insufficiency or diagnosed with acute clinical viral hepatitis Diagnosed with Mycobacterium tuberculosis infection Severe laboratory abnormalities Creatinine clearance less than 50 mL per minute Addicted to drug, including alcohol or recreational drugs
Patients will receive fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate/emtricitabine/rilpivirine with a meal, until Week 48.
Drug: Rilpivirine · Drug: Tenofovir disoproxil fumarate · Drug: Emtricitabine
Patients will receive FDC tablet of tenofovir disoproxil fumarate/emtricitabine /efavirenz on an empty stomach at bedtime, until Week 48.
Drug: Efavirenz · Drug: Tenofovir disoproxil fumarate · Drug: Emtricitabine
Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
Also known as: EDURANT
Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.
Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
Percentage of Participants with plasma HIV-1 RNA \<50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA \>=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<400 copies/mL.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA \>=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<50 copies/mL.
Time frame: Week 48
Percentage of Participant With Treatment Adherence Based on Tablet Count
In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of \>95% (97% and 98% in RPV and EFV treated treatment groups respectively).
Time frame: Up to 48 Weeks
Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
To compare the loss of treatment options, the number of participants with treatment-emergent N\[t\]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.
Time frame: Up to Week 48
| Milestone | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Started | 213 | 213 |
| Treated | 213 | 211 |
| Completed | 197 | 198 |
| Not completed | 16 | 15 |
| Withdrew: Lost to follow-up | 4 | 7 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Adverse event | 5 | 0 |
| Withdrew: Other | 5 | 3 |
| Withdrew: Participant reached a virologic endpoint | 0 | 1 |
| Withdrew: Not treated | 0 | 2 |
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
| Percentage of Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48 | 93.9 (-6.44 to —) | 96.2 |
Percentage of Participants with plasma HIV-1 RNA \<50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.
| Percentage of Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48 | 93.9 | 96.2 |
Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA \>=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<400 copies/mL.
| Percentage of Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. | 0.5 | 0.5 |
Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA \>=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression \<50 copies/mL.
| Percentage of Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. | 1.5 | 1.0 |
In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of \>95% (97% and 98% in RPV and EFV treated treatment groups respectively).
| Percentage of Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Percentage of Participant With Treatment Adherence Based on Tablet Count | 97.2 ± 1.981 | 97.6 ± 1.649 |
To compare the loss of treatment options, the number of participants with treatment-emergent N\[t\]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.
| Participants | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TDF/FTC/RPV | — | 16/213 (7.5%) | 128/213 (60.1%) |
| TDF/FTC/EFV | — | 11/211 (5.2%) | 137/211 (64.9%) |
| Event | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Diabetes MellitusMetabolism and nutrition disorders | 3/213 | 0/211 |
| HyperglycaemiaMetabolism and nutrition disorders | 2/213 | 0/211 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 2/213 | 1/211 |
| AnaemiaBlood and lymphatic system disorders | 0/213 | 1/211 |
| NeutropeniaBlood and lymphatic system disorders | 0/213 | 1/211 |
| Gastrointestinal InflammationGastrointestinal disorders | 0/213 | 1/211 |
| Food AllergyImmune system disorders | 0/213 | 1/211 |
| SinusitisInfections and infestations | 0/213 | 1/211 |
| Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/213 | 1/211 |
| Cervix CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/213 | 1/211 |
| Event | TDF/FTC/RPV | TDF/FTC/EFV |
|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 63/213 | 59/211 |
| HeadacheNervous system disorders | 38/213 | 29/211 |
| Urinary Tract InfectionInfections and infestations | 29/213 | 28/211 |
| MalariaInfections and infestations | 10/213 | 22/211 |
| Back PainMusculoskeletal and connective tissue disorders | 20/213 | 14/211 |
| VertigoEar and labyrinth disorders | 11/213 | 19/211 |
| CoughRespiratory, thoracic and mediastinal disorders | 19/213 | 7/211 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/213 | 15/211 |
| DizzinessNervous system disorders | 7/213 | 14/211 |
| Amylase IncreasedInvestigations | 14/213 | 5/211 |
| Age, Continuous(years) | TDF/FTC/RPV | TDF/FTC/EFV | Total |
|---|---|---|---|
| Mean | 40.6 ± 8 | 40.6 ± 8.7 | 40.6 ± 8.34 |
| Sex: Female, Male(Participants) | TDF/FTC/RPV | TDF/FTC/EFV | Total |
|---|---|---|---|
| Female | 137 | 134 | 271 |
| Male | 76 | 77 | 153 |
| Region of Enrollment(participants) | TDF/FTC/RPV | TDF/FTC/EFV | Total |
|---|---|---|---|
| CAMEROON | 16 | 13 | 29 |
| KENYA | 36 | 37 | 73 |
| SENEGAL | 17 | 8 | 25 |
| SOUTH AFRICA | 33 | 30 | 63 |
| THAILAND | 51 | 58 | 109 |
| UGANDA | 60 | 65 | 125 |
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Acquired Immunodeficiency Syndrome→
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