Status:
WITHDRAWN
Antiretroviral Therapy for Acute HIV Infection
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.
Detailed Description
This is a prospective, open-label study to describe the effects of early antiretroviral (ART) therapy on 1) viral load, 2) safety and tolerability of Genvoya®, 3) clinical outcomes and secondarily on ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- There are no inclusion/exclusion criteria based on CD4 count because CD4 count can be transiently diminished during acute HIV infection and ART initiation during early or acute HIV infection offers the potential benefit of limiting reservoir seeding and preventing immune destruction regardless of peripheral CD4 count at the time of treatment initiation.
Key Trial Info
Start Date :
March 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03877536
Start Date
March 17 2019
End Date
September 14 2025
Last Update
April 26 2019
Active Locations (1)
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1
Makerere University--Walter Reed Project (MUWRP)
Kampala, Uganda