HIV/AIDS
Conditions
Interventions
Tenofovir Lamivudine and Dolutegravir TLD
Elsulfavirine and Dolutegravir ED
Tenofovir Lamivudine and Elsulfavirine TLE
Sponsors
AMA Manufacturing Factory
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provides written informed consent prior to the initiation of any trial procedures. 2. A recently confirmed HIV positive test result within the last one month. 3. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits. 4. Age = 18 years at time of enrollment. 5.Not pregnant: 5a. Participants of childbearing potential must have a negative serum human chronic gonadotropin (HCG) pregnancy test at screening and a negative urine HCG pregnancy test within 24 hours prior to the study treatment administration. And those Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, salpingectomy, or Essure® placement with history of documented radiological confirmation test at least 60 days after the procedure). 5b. Participants of childbearing potential in a heterosexual relationship agree to use of highly effective contraception beginning at the time of the screening visit through Day 24 weeks of the study treatment). Acceptable forms of primary contraception include true abstinence (100% of time no insertional sexual intercourse), monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant receiving the Study treatment, intrauterine devices, birth control pills, condoms with spermicide, and injectable/implantable/insertable/transdermal hormonal birth control products. Must use at least one acceptable primary form of contraception for at least 30 days prior to enrollment and through the end of the study 6. Vital signs are in the following ranges at screening: • Oral temperature is less than 38.0°C. • Pulse is 47 to 100 beats per minute, inclusive. • Systolic blood pressure (SBP) is 85 to 140 mmHg, inclusive. • Diastolic blood pressure (DBP) is 55 to 90 mmHg, inclusive.
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Chronic Kidney Failure (maximum acceptable = eGFR 60 ml /min/1.73m2) 3. HBsAg reactive 4. HCVAb reactive 5. Heamoglobin concentration 5× Uper limit of normal [ULN])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Mean changes in viral load across the three (ED, TLE & TLD) groups b) Proportion of patients achieving viral suppression (HIV-1 RNA < 50 copies/mL) c) Proportion of participants with CD4+ count = 200 count /dl d) Incidence of adverse events and grade 3/4 laboratory abnormalities across the three arms | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of of discontinuations due to adverse events and/or due to grade 3/4 laboratory abnormalities across the three arms | — |
Countries
Nigeria
Contacts
Public ContactAdamu;Ikunaiye Adamu;Nasiru
University of Maiduguri Teaching Hospital;University of Maiduguri Teaching Hospital
Outcome results
None listed