Clinical Trial Search

Primary: Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP) — 10; 15 participants — p=0.2434

Primary: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants — 0.65; 0.50; 1.99 events per 100 person years — p=<0.001

Primary: Total Treatment-free Time to Initiation of Permanent HAART — 18; 18 months

Primary: HIV Seroconversion — 48; 83 Participants — p=0.002

Primary: Number of Adverse Event Occurrences — 38; 28; 28; 14 events

Primary: Evidence of Toxicity. Toxicity Was Measured as Any Adverse Event; Nausea, Vomiting, Diarrhea. Elevated Liver Function Tests. — 4; 4 adverse events

Primary: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms — 91.2; 88.2 percentage of participants with AE — p=0.003

Primary: Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit — 125; 157 HIV Exposure Events — p=<0.05

Primary: Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing — 75; 56; 52; 85 percentage of sexual exposures

Primary: Medication Regimen Completion Rates — 57; 28; 15 participants

Primary: Estimated Threshold of Maternal Steady-state Tenofovir Diphosphate (TFV-DP) Concentration Levels Corresponding to Optimal Adherence in the PK Component — 965; 1050…

Primary: Incidence-density of Malaria Defined as the Number of Incident Episodes of Malaria Per Time at Risk. — 1.32; 2.25 Episodes/ Person-Yr at Risk — p=0.04

Primary: Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens. — 93; 77; 70; 80 participants

Primary: Occurrence of Grade 3 or Higher Adverse Events (AEs) — 18; 24; 20; 28 Participants

Primary: Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART — -4.01 % of CD8+ T-cells — p=0.001

Primary: Probability of Relapse-free Survival — 79; 71 percentage probability

Primary: The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV — NA; 669.90; 265.10; 979.8 ng/mL

Primary: CD4+ Level — 162.3; 50.5; 143.3; 69.9 cell/μL — p=0.02

Primary: Adverse Effects — 1 Participants

Primary: Number of Participants in Each Condition With Optimal ART Adherence — 27; 29 participants

Primary: The Antiretroviral Treatment Failure Rate at 12 Months. — 4; 5 participants — p=1.00

Primary: HIV Infection — 33; 35 participants

Primary: Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up — 78; 39 Participants

Primary: The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package — 148…

Primary: Engagement in Care (Implementation Component) — 1; 1 Participants

Primary: Number of Serious Adverse Events (SAEs) — 12; 7 Events

Primary: Infant HIV Infection Status — 24; 11; 12 participants — p=.046

Primary: Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study — 0 Participants

Primary: Percentage of Participants With Early Virologic Response — 80.8 percentage of participants

Primary: Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine — 0 participants