Antiretroviral Therapy for Acute HIV Infection

NCT03877536 | Withdrawn

• 2 other identifiers: RV 392WRAIR 2393
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• Plasma viral load

  The number of study participants with plasma viral load \<50 copies/mL

  Measured at 48 weeks after enrollment

• Plasma viral load

  The number of study participants with plasma viral load \<50 copies/mL

  Measured at 96 weeks after enrollment

• Drug-related AEs and SAEs

  Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.

  Measured through week 96

• Treatment Discontinuation for AEs up to 96 weeks

  Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks

  Measured through week 96

Secondary Outcomes (3)

• CD4+ T cell count change

  Measured over 48 weeks

• Frequency of HIV-related illnesses

  Measured through week 96

• Duration of HIV-related illnesses

  Measured through week 96

Other Outcomes (5)

• Changes in HIV-specific immune responses over time

  Measured through week 96

• Host humoral (IgG) responses

  Measured through week 96

• Markers of Immune Activation

  Measured through week 96

Study Arms (1)

Genvoya 150Mg-150Mg-200Mg-10Mg Tablet

EXPERIMENTAL

Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.

Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet

Interventions

Genvoya 150Mg-150Mg-200Mg-10Mg Tablet DRUG

Participants will receive 1 tablet per day throughout study duration (96 weeks).

Genvoya 150Mg-150Mg-200Mg-10Mg Tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First identified as an incident HIV infection within one year of estimated time of infection in RV 217.
• Willing to begin Genvoya® as soon as entering this study but not later than 7 days from study enrollment.
• Successfully passed Test of Understanding (TOU) with a score of 80% or more on ten questions after three attempts.
• Adult from 18 to 50 years of age.
• Able to participate for 96 weeks of study visits
• In general good health as determined by the PI or his/her designee
• Willing to have photo or fingerprint taken for identification purposes
• No history of ART for any reason, i.e., treatment naïve and no HIV-post-exposure prophylaxis (PEP) or HIV-pre-exposure prophylaxis (PrEP)) within 90 days prior to enrollment
• Willing to have blood samples collected and stored.
• Adequate renal function: estimated creatine clearance of \>50 mL/min according to the Cockroft Gault formula 2 weeks prior to enrollment
• Urine clean catch: glucose \< trace and protein \<1+ or as per site-specification 2 weeks prior to enrollment
• Weight is \> 35 kg
• Female (only women of childbearing potential) Specific Criteria:
• Negative pregnancy test 48 hours prior to enrollment:
• Commits to continued use of adequate birth control method for 96 weeks of the study and prior to receiving study ART. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device (IUD), or abstinence. If depending on hormonal contraception, check package insert for drug interactions and/or consider adding a second barrier method.

You may not qualify if:

• Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer, including but not limited to chronic hepatitis, renal insufficiency or failure; clinically significant forms of drug or alcohol abuse, mental illness, severe asthma, psychiatric disorders, heart disease, or cancer; or a physical finding on examination considered indicative of significant disease such as murmur (other than functional), hepatosplenomegaly, focal neurological deficit, etc.
• Untreated AIDS-related opportunistic infection
• An AIDS defining condition diagnosed within 30 days
• Positive Hepatitis B surface antigen at any time in the past
• Requiring use of any medication that is contraindicated with Genvoya®. See Appendix I and the package insert
• Women who are breast-feeding

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Gilead Sciences: collaborator

Study Sites (1)

Makerere University--Walter Reed Project (MUWRP)

Kampala, Uganda

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cobicistat; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Christina Polyak, MD, MPH

  Henry M. Jackson Foundation in support of MHRP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, open-label study

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: March 15, 2019
• Study Start: March 17, 2019
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2025
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)