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| ID | Type | Description | Link |
|---|---|---|---|
| 2UM1AI068636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This study was done to see if the combination of two anti-HIV medicines, dolutegravir (DTG, Tivicay) and lamivudine (3TC, Epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for HIV. DTG is a type of HIV medicine called an integrase inhibitor; 3TC is a type of HIV medicine called a reverse transcriptase inhibitor. DTG works by blocking integrase and 3TC works by blocking reverse transcriptase, two HIV proteins (enzymes). This prevents HIV from multiplying and lowers the viral load (amount of HIV in the blood). Both DTG and 3TC are currently part of Food and Drug Administration (FDA) recommended regimens along with a third active drug. Since some HIV medicines have side effects and are costly, there is interest in whether HIV can be successfully controlled with fewer than three HIV drugs.
This study was a phase II, single-arm, open-label pilot study designed to estimate the efficacy of dolutegravir (DTG) plus lamivudine (3TC) as initial combination ART (antiretroviral therapy) in HIV-1 infected treatment naive participants. The target enrollment was 120 participants with a cap of N=90 participants with screening HIV-1 RNA <= 100,000 copies/mL. The study aimed to enroll >= 20% women. The expected follow-up for each participant was 52 weeks.
Visits occurred at screening, entry, and weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 from study entry. All signs/symptoms within 30 days prior to entry were recorded. Subsequently, grade 2 or higher rash and all other grade 3 or higher signs and symptoms were recorded. All participants underwent routine monitoring including plasma HIV-1 RNA levels, CD4+ cell count, hematology, chemistry, urinalysis, and pregnancy testing (for women of reproductive potential).
Population-based protease (PR), reverse transcriptase (RT) and integrase genotyping were done at the time of confirmed virologic failure. Plasma samples were stored for potential future studies to assess the impact of adherence, drug-resistant minority viral variants, and DTG exposure on virologic and CD4+ cell count responses to DTG plus 3TC. All participants also underwent UGT1A1 genotyping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: DTG 50 mg + 3TC 300 mg | Experimental | Dolutegravir 50mg and Lamivudine 300mg, orally daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug | Participants were prescribed 50 mg of DTG orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Status at Week 24 | Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). | At 24 weeks after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Status at Week 12 | Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). | At 12 weeks after study entry |
| Virologic Status at Week 48 |
Not provided
NOTE: Further information on the eligibility criteria can be found in the study protocol.
Inclusion Criteria:
HIV-1 infection.
Plasma HIV-1 RNA ≥1000 copies/mL and <500,000 copies/mL obtained within 90 days prior to study entry.
No evidence of any RT, any integrase, or major protease resistance mutation (according to the 2014 IAS-USA drug resistance mutations list, available at https://www.iasusa.org/sites/default/files/tam/22-3-642.pdf) based on pre-ARV (antiretroviral) treatment genotype performed any time prior to study entry.
ARV treatment drug-naive (defined as no previous ARV treatment at any time prior to study entry, with the exception of successful post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).
The following laboratory values obtained within 45 days prior to study entry:
Hepatitis B surface antigen negative within 45 days prior to study entry.
For women with reproductive potential, negative serum or urine pregnancy test at screening and within 48 hours prior to study entry.
If participating in sexual activity that could lead to pregnancy, female participants with reproductive potential must have agreed to use one form of contraceptive as listed in the protocol while receiving protocol-specified medications and for 30 days after stopping the medications.
Ability and willingness of participant or legal representative to provide informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Gulick, MD, MPH | Weill Medical College of Cornell University | Study Chair |
| Babafemi Taiwo, MBBS | Northwestern University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California CRS (1201) | Los Angeles | California | 90033 | United States | ||
| UCLA CARE Center CRS (601) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30668695 | Derived | Nyaku AN, Zheng L, Gulick RM, Olefsky M, Berzins B, Wallis CL, Godfrey C, Sax PE, Acosta EP, Haas DW, Smith KY, Sha BE, Van Dam CN, Taiwo BO; ACTG A5353 Study Team. Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353. J Antimicrob Chemother. 2019 May 1;74(5):1376-1380. doi: 10.1093/jac/dky564. | |
| 29253097 | Derived | Taiwo BO, Zheng L, Stefanescu A, Nyaku A, Bezins B, Wallis CL, Godfrey C, Sax PE, Acosta E, Haas D, Smith KY, Sha B, Van Dam C, Gulick RM. ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis. 2018 May 17;66(11):1689-1697. doi: 10.1093/cid/cix1083. |
| Label | URL |
|---|---|
| DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 November 2014 | View source |
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A total of 122 participants were accrued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: DTG 50 MG + 3TC 300 mg | Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2016 | Feb 26, 2018 |
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| Lamivudine | Drug | Participants were prescribed 300 mg of 3TC orally daily. |
|
|
Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). |
| At 48 weeks after study entry |
| Virologic Failure | Virologic failure is defined as follows:
| Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population. | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| CD4+ Cell Count | CD4+ cell counts by study week. | Baseline, weeks 4, 12, 24, and 48 |
| Change in CD4+ Cell Count | Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline. | Baseline, weeks 4, 12, 24, and 48 |
| Number of HIV-1 Drug Resistance Mutation Occurrences in Participants | Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations. | at the time of virologic failure |
| Fasting Lipids and Glucose | Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection. | Baseline and week 48 |
| Creatinine Clearance | Creatinine clearance was estimated by the Cockcroft-Gault equation. | Baseline, weeks 4, 12, 24, 32, 40 and 48 |
| Number of Participants With Grade 3 of Higher Adverse Events | Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. | from study treatment dispensation through up to week 52 or until study discontinuation |
| Los Angeles |
| California |
| 90095 |
| United States |
| Ucsd, Avrc Crs (701) | San Diego | California | 92103 | United States |
| Harbor-UCLA Med. Ctr. CRS (603) | Torrance | California | 90502 | United States |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | United States |
| Univ. of Miami AIDS CRS (901) | Miami | Florida | 33136 | United States |
| The Ponce de Leon Center CRS (5802) | Atlanta | Georgia | 30308 | United States |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | United States |
| Rush Univ. Med. Ctr. ACTG CRS (2702) | Chicago | Illinois | 60612 | United States |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | United States |
| Washington University CRS (2101) | St Louis | Missouri | 63110 | United States |
| Cornell CRS (7804) | New York | New York | 10011 | United States |
| Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803) | New York | New York | 10011 | United States |
| Columbia Physicians and Surgeons CRS (30329) | New York | New York | 10032 | United States |
| University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787) | Rochester | New York | 14642 | United States |
| 3201 Chapel Hill CRS | Chapel Hill | North Carolina | 27516 | United States |
| Greensboro CRS (3203) | Greensboro | North Carolina | 27401 | United States |
| Univ. of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | United States |
| The Ohio State Univ. AIDS CRS (2301) | Columbus | Ohio | 43210 | United States |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | United States |
| The Miriam Hospital ACTG CRS (2951) | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37204 | United States |
| 31443 Trinity Health and Wellness Center CRS | Dallas | Texas | 75208 | United States |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | United States |
| Puerto Rico-AIDS CRS (5401) | San Juan | 00935 | Puerto Rico |
| FDA Snapshot Definition (refer to Appendix A in FDA Snapshot PDF) | View source |
| DAIDS Adverse Events Manual, Version 2.0 January 2010 | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible participants enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: DTG 50 MG + 3TC 300 mg | Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Intravenous Drug Use | Count of Participants | Participants |
| ||||||||||||||||||
| CD4 Count, Continuous | 2 participants with missing baseline CD4 counts. | Median | Inter-Quartile Range | cells/mm^3 |
| ||||||||||||||||
| CD4 Count, Categorized | Count of Participants | Participants |
| ||||||||||||||||||
| CD8 Count | Total of 13 participants missing CD8 Count at baseline. | Median | Inter-Quartile Range | cells/mm^3 |
| ||||||||||||||||
| CD4/CD8 Ratio | Total of 13 participants had missing measurements that contribute to the CD4/CD8 ratio. | Median | Inter-Quartile Range | ratio |
| ||||||||||||||||
| Screening HIV-1 RNA | Median | Inter-Quartile Range | log10 copies/mL |
| |||||||||||||||||
| Baseline HIV-1 RNA | Baseline HIV-1 RNA is defined as the last nonmissing observation on or prior to first dose date after screening. | Median | Inter-Quartile Range | log10 copies/mL |
| ||||||||||||||||
| Baseline HIV-1 RNA Category | Baseline HIV-1 RNA is defined as the last nonmissing observation on or prior to first dose date after screening. | Count of Participants | Participants |
| |||||||||||||||||
| Hepatitis C Antibody Status | Count of Participants | Participants |
| ||||||||||||||||||
| Post-exposure Prophylaxis or Pre-Exposure Prophylaxis History | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Virologic Status at Week 24 | Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). | All eligible participants enrolled. | Posted | Count of Participants | Participants | At 24 weeks after study entry |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Status at Week 12 | Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). | All eligible participants enrolled. | Posted | Count of Participants | Participants | At 12 weeks after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Status at Week 48 | Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below. Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition). | All eligible participants enrolled. | Posted | Count of Participants | Participants | At 48 weeks after study entry |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Failure | Virologic failure is defined as follows:
| All eligible participants enrolled. | Posted | Count of Participants | Participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population. | The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population. | The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population. | ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population. | ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated | Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population. | As Treated: purely virologic missing = ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated | Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population. | As Treated: purely virologic missing=ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week. | Posted | Number | 95% Confidence Interval | proportion of participants | Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CD4+ Cell Count | CD4+ cell counts by study week. | All eligible participants enrolled with CD4 count results available at a given visit. | Posted | Median | Inter-Quartile Range | cells/mm^3 | Baseline, weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4+ Cell Count | Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline. | All eligible participants enrolled with CD4 cell count results available at baseline and the given visit. | Posted | Median | Inter-Quartile Range | cells/mm^3 | Baseline, weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of HIV-1 Drug Resistance Mutation Occurrences in Participants | Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations. | Of the enrolled eligible participants, those with virologic failures had resistance testing done. | Posted | Number | number of mutation occurrences | at the time of virologic failure |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Lipids and Glucose | Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection. | All eligible participants enrolled with lipids results available at a given time point. | Posted | Median | Inter-Quartile Range | mg/dL | Baseline and week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Creatinine Clearance | Creatinine clearance was estimated by the Cockcroft-Gault equation. | All eligible participants enrolled with creatinine clearance results available at a given time point. | Posted | Median | Inter-Quartile Range | mL/min | Baseline, weeks 4, 12, 24, 32, 40 and 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3 of Higher Adverse Events | Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. | All eligible participants enrolled. | Posted | Count of Participants | Participants | from study treatment dispensation through up to week 52 or until study discontinuation |
|
|
From study entry through up to week 52 or until study discontinuation
The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of >= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: DTG 50 MG + 3TC 300 mg | Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily. | 0 | 122 | 3 | 122 | 75 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urethritis gonococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG Clinicaltrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 14, 2015 | Feb 28, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| C562325 | dolutegravir |
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
Not provided
Not provided
|
| 40-49 years |
|
| 50-59 years |
|
| >= 60 years |
|
|
| Hispanic (Regardless of Race) |
|
| Asian, Pacific Islander |
|
| More than one race |
|
| Does not want to report |
|
|
|
| Previously |
|
|
| 350-499 cells/mm^3 |
|
| 500-649 cells/mm^3 |
|
| 650-799 cells/mm^3 |
|
| >=800 cells/mm^3 |
|
| Missing |
|
| 1,000 - 9,999 copies/mL |
|
| 10,000 - 99,999 copies/mL |
|
| 100,000 - 200,000 copies/mL |
|
| > 200,000 copies/mL |
|
|
|
|
|
|
|
|
|
|
|
|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 |
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| Week 4 |
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| Week 12 |
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| Week 24 |
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| Week 48 |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 |
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| Week 4 |
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| Week 12 |
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| Week 24 |
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| Week 32 |
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| Week 40 |
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| Week 48 |
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