Table 3.
Clinical studies related to HIV infection.
| Name of the Clinical Trial | ClinicalTrials.gov Identifier |
Phase | Actual Study Start Date | Estimated Study Completion Date or Completion Date |
|---|---|---|---|---|
| A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination with Lenacapavir in Virologically Suppressed People with HIV | NCT05052996 | Phase 2 | 5 October 2021 | November 2027 |
| A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) | NCT05766501 | Phase 2 | 17 March 2023 | 14 January 2026 |
| A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1-Infected Treatment-Naïve Participants | NCT04233879 | Phase 3 | 28 February 2020 | 3 March 2025 |
| Safety of and Immune Response to Dolutegravir in HIV-1-Infected Infants, Children, and Adolescents | NCT01302847 | Phase 1/2 | 20 April 2011 | 20 January 2024 |
| A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination with Lenacapavir in Virologically Suppressed People with HIV | NCT05052996 | Phase 2 | 5 October 2021 | November 2027 |
| A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) | NCT05766501 | Phase 2 | 17 March 2023 | 14 January 2026 |
| Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study) (EPIC-HIV) | NCT03207945 | Phase 3 | 30 April 2018 | July 2025 |
| Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection (PURPOSE 1) | NCT04994509 | Phase 3 | 30 August 2021 | July 2027 |
| Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection (PURPOSE 2) | NCT04925752 | Phase 3 | 28 June 2021 | April 2027 |
| Italian Registry of HIV-1-Infected Patients with Drug-RESistant Virus to Reverse Transcriptase Inhibitors, InteGrasE and Viral Protease. (PRESTIGIO) | NCT04098315 | Observational | 14 December 2017 | 31 December 2028 |
| A Randomised Placebo Controlled Trial of ART Plus Dual Long-acting HIV-specific Broadly Neutralising Antibodies (bNAbs). (RIO) | NCT04319367 | Phase 2 | 17 May 2021 | 31 March 2025 |
| Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) | NCT02652260 | Phase 2 | 4 March 2016 | 29 February 2024 |
| Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007) | NCT06045507 | Phase 2 | 8 November 2023 | 18 February 2025 |
| A Clinical Trial of STP0404 in Treatment-Naïve Adults with HIV-1 Infection | NCT05869643 | Phase 2 | 23 May 2023 | 13 May 2024 |
| HIV-1-Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label (DORAL) | NCT04513626 | Phase 2 | 15 September 2020 | 30 October 2024 |
| Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide | NCT04636437 | Phase 4 | 20 May 2021 | 31 October 2024 |
| CAR-T Cells for HIV Infection | NCT04648046 | Phase 1/2 | 1 March 2021 | 31 December 2027 |
| Study to Evaluate Pharmacokinetic and Safety of Albuvirtide between Intravenous Drip and Intravenous Injection | NCT05206019 | Phase 1 | 16 February 2022 | Completed 2 May 2022 |
| An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) with Dolutegravir Plus Tenofovir/Emtricitabine in the Treatment of Naïve HIV Infected Participants (Gemini 2) | NCT02831764 | Phase 3 | 18 July 2016 | Completed 26 June 2022 |
| An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine with Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1) | NCT02831673 | Phase 3 | 21 July 2016 | Completed 15 August 2022 |
| Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) | NCT03446573 | Phase 3 | 18 January 2018 | Completed 3 May 2022 |
| Islatravir (MK-8591) with Doravirine and Lamivudine in Participants Infected with Human Immunodeficiency Virus Type 1 (MK-8591-011) | NCT03272347 | Phase 2 | 27 November 2017 | Completed 9 March 2022 |
| Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1)-Infected, Antiretroviral Treatment-Naive Adults | NCT02607956 | Phase 3 | 11 November 2015 | Completed 5 July 2021 |
| Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1)-Infected, Antiretroviral Treatment-Naive Adults | NCT02607930 | Phase 3 | 13 November 2015 | Completed 2 July 2021 |
| Safety and Efficacy of Switching from Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1-Infected Adults Who Are Virologically Suppressed | NCT02603120 | Phase 3 | 11 November 2015 | Completed 23 October 2019 |
| Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1-Infected Adults | NCT02603107 | Phase 3 | 20 November 2015 | Completed 23 December 2019 |
| Safety and Efficacy of Switching to an FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1-Infected Women | NCT02652624 | Phase 3 | 19 February 2016 | Completed 26 November 2018 |
| Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women | NCT02858037 | Phase 3 | 18 July 2016 | Completed 10 October 2018 |