HIV-1 Infection Clinical Trial
Official title:
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA) and Lopinavir/Ritonavir (LPV/r) and of the Effects of DMPA on Cellular Immunity and Regulation in HIV-Infected Women
This study was done to look at the level of Depo-Provera, an injectable birth control, in the blood to see whether it is affected by the anti-HIV drug Kaletra (lopinavir/ritonavir [LPV/r]). It is not known whether taking Depo-Provera together with Kaletra changes the amount of Kaletra in blood. Therefore, this study also looked at the levels of HIV and Kaletra before and after receiving a shot of Depo-Provera. This study evaluated the safety of Depo-Provera and Kaletra when they are used together. In addition to what is stated above, this study also explored any effect of Depo-Provera on the immune system.
The primary study objective was addressed by calculating the Area Under the
Concentration-Time Curve (AUC) from week 0 (prior to DMPA injection) to week 12 (twelve
weeks after DMPA injection) in our study participants.
DMPA was supplied and administered as part of the protocol, however Kaletra was not. It was
required that participants already be on a Kaletra based regimen prior to entering the
study, as described in the eligibility criteria.
Arm A of AIDS Clinical Trial Group (ACTG) A5093, which consisted of 14 participants who were
administered DMPA without Kaletra, was used as reference data.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03188523 -
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
|
Phase 1 | |
| Active, not recruiting |
NCT06185452 -
Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine
|
Phase 4 | |
| Recruiting |
NCT02881320 -
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1
|
Phase 2/Phase 3 | |
| Completed |
NCT02542852 -
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable Viremia
|
Phase 2 | |
| Completed |
NCT02513771 -
Sitagliptin for Reducing Inflammation and Immune Activation
|
Phase 2 | |
| Terminated |
NCT02732457 -
Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Infected Patients
|
||
| Completed |
NCT02057796 -
Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
|
Phase 4 | |
| Completed |
NCT01989910 -
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
|
Phase 4 | |
| Completed |
NCT01627678 -
Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART
|
Phase 1/Phase 2 | |
| Completed |
NCT01704781 -
Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
|
Phase 1/Phase 2 | |
| Completed |
NCT01348308 -
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
|
Phase 3 | |
| Completed |
NCT01403051 -
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
|
Phase 2 | |
| Completed |
NCT01466595 -
Rifaximin as a Modulator of Microbial Translocation and Immune Activation
|
Phase 2 | |
| Completed |
NCT01511809 -
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
|
Phase 3 | |
| Completed |
NCT01019551 -
Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients
|
Phase 2 | |
| Terminated |
NCT01130376 -
Novel Interventions in HIV-1 Infection
|
Phase 1 | |
| Completed |
NCT00323687 -
SONETT: Switch Study to Once Daily HIV Treatment Regimen With Truvada
|
Phase 4 | |
| Completed |
NCT04003103 -
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
|
Phase 2 | |
| Completed |
NCT02527096 -
A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)
|
Phase 2 | |
| Active, not recruiting |
NCT04776252 -
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
|
Phase 3 |